Trial Outcomes & Findings for Polypill in Acute Coronary Syndrome (NCT NCT05514938)
NCT ID: NCT05514938
Last Updated: 2026-05-14
Results Overview
Within group change and between-group difference, polypill vs usual care. Represented as least squares means from linear regression models adjusting for baseline values, comparing polypill strategy versus usual care. The two relevant time points included baseline and 1 month laboratory values.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
140 participants
Primary outcome timeframe
1 month
Results posted on
2026-05-14
Participant Flow
All enrolled participants were randomized.
Participant milestones
| Measure |
Polypill
Patients will be randomized to receiving a fixed-dose polypill in addition to other guideline-directed medical therapies prescribed by their physician. Enrolled participants were kept on the P2Y12 inhibitor (clopidogrel or prasugrel) prescribed by their primary medical team. Polypill formulations will include rosuvastatin 40 mg, aspirin 81 mg, and prasugrel 10 mg daily or rosuvastatin 40 mg, aspirin 81 mg, and clopidogrel 75 mg.
Polypill: Polypill formulation consisting of rosuvastatin, aspirin, and prasugrel or consisting of rosuvastatin, aspirin, and clopidogrel.
|
Usual Care (Individual Medications Prescribed by Primary Cardiologist)
Patients will receive usual post-ACS care and medications prescribed by their provider. All of the individual components will be available at low- or no-cost to participants as individual pill formulations.
Usual Care (individual medications prescribed by primary cardiologist): Typical prescriptions for post-acute coronary syndrome care including statin, aspirin, and prasugrel or clopidogrel.
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
71
|
|
Overall Study
COMPLETED
|
65
|
63
|
|
Overall Study
NOT COMPLETED
|
4
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Polypill in Acute Coronary Syndrome
Baseline characteristics by cohort
| Measure |
Polypill
n=69 Participants
Patients will be randomized to receiving a fixed-dose polypill in addition to other guideline-directed medical therapies prescribed by their physician. Polypill formulations will include rosuvastatin 40 mg, aspirin 81 mg, and prasugrel 10 mg daily or rosuvastatin 40 mg, aspirin 81 mg, and clopidogrel 75 mg.
Polypill: Polypill formulation consisting of rosuvastatin, aspirin, and prasugrel or consisting of rosuvastatin, aspirin, and clopidogrel.
|
Usual Care (Individual Medications Prescribed by Primary Cardiologist)
n=71 Participants
Patients will receive usual post-ACS care and medications prescribed by their provider. All of the individual components will be available at low- or no-cost to participants as individual pill formulations.
Usual Care (individual medications prescribed by primary cardiologist): Typical prescriptions for post-acute coronary syndrome care including statin, aspirin, and prasugrel or clopidogrel.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
n=1512 Participants
|
61 years
n=504 Participants
|
58 years
n=2016 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=1512 Participants
|
20 Participants
n=504 Participants
|
41 Participants
n=2016 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=1512 Participants
|
51 Participants
n=504 Participants
|
99 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
41 Participants
n=1512 Participants
|
47 Participants
n=504 Participants
|
88 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=1512 Participants
|
24 Participants
n=504 Participants
|
52 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=1512 Participants
|
4 Participants
n=504 Participants
|
5 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=1512 Participants
|
8 Participants
n=504 Participants
|
20 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=1512 Participants
|
59 Participants
n=504 Participants
|
114 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
P2Y12 Inhibitor at randomization
Prasugrel
|
44 Participants
n=1512 Participants
|
42 Participants
n=504 Participants
|
86 Participants
n=2016 Participants
|
|
P2Y12 Inhibitor at randomization
Clopidogrel
|
25 Participants
n=1512 Participants
|
29 Participants
n=504 Participants
|
54 Participants
n=2016 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Participants who completed the 1-month study visit with LDL-C
Within group change and between-group difference, polypill vs usual care. Represented as least squares means from linear regression models adjusting for baseline values, comparing polypill strategy versus usual care. The two relevant time points included baseline and 1 month laboratory values.
Outcome measures
| Measure |
Polypill
n=65 Participants
Patients will be randomized to receiving a fixed-dose polypill in addition to other guideline-directed medical therapies prescribed by their physician. Polypill formulations will include rosuvastatin 40 mg, aspirin 81 mg, and prasugrel 10 mg daily or rosuvastatin 40 mg, aspirin 81 mg, and clopidogrel 75 mg.
Polypill: Polypill formulation consisting of rosuvastatin, aspirin, and prasugrel or consisting of rosuvastatin, aspirin, and clopidogrel.
|
Usual Care (Individual Medications Prescribed by Primary Cardiologist)
n=63 Participants
Patients will receive usual post-ACS care and medications prescribed by their provider. All of the individual components will be available at low- or no-cost to participants as individual pill formulations.
Usual Care (individual medications prescribed by primary cardiologist): Typical prescriptions for post-acute coronary syndrome care including statin, aspirin, and prasugrel or clopidogrel.
|
|---|---|---|
|
Low Density Lipoprotein - Cholesterol
|
-6.74 mg/dL
Interval -12.03 to -1.46
|
0.53 mg/dL
Interval -6.75 to 7.81
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Participants who completed the 1 month follow-up
Within-group change and between-group changes in platelet reactivity at 30 days. Platelet reactivity was assessed using impedance aggregometry (Ohms, Ω, lower = better platelet inhibition). The two relevant time points included baseline and 1 month laboratory values.
Outcome measures
| Measure |
Polypill
n=65 Participants
Patients will be randomized to receiving a fixed-dose polypill in addition to other guideline-directed medical therapies prescribed by their physician. Polypill formulations will include rosuvastatin 40 mg, aspirin 81 mg, and prasugrel 10 mg daily or rosuvastatin 40 mg, aspirin 81 mg, and clopidogrel 75 mg.
Polypill: Polypill formulation consisting of rosuvastatin, aspirin, and prasugrel or consisting of rosuvastatin, aspirin, and clopidogrel.
|
Usual Care (Individual Medications Prescribed by Primary Cardiologist)
n=63 Participants
Patients will receive usual post-ACS care and medications prescribed by their provider. All of the individual components will be available at low- or no-cost to participants as individual pill formulations.
Usual Care (individual medications prescribed by primary cardiologist): Typical prescriptions for post-acute coronary syndrome care including statin, aspirin, and prasugrel or clopidogrel.
|
|---|---|---|
|
Platelet Reactivity
|
0.55 ohms
Interval -0.32 to 1.43
|
0.76 ohms
Interval 0.09 to 1.44
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Participants who presented for 1 month follow-up visit.
Within group and between group difference in Morisky Medication Adherence Scale - 8, a self-reported adherence questionnaire that ranges from 0-8, where 8 = highest adherence, and 0 = lowest adherence. The two relevant time points included baseline and 1 month values.
Outcome measures
| Measure |
Polypill
n=65 Participants
Patients will be randomized to receiving a fixed-dose polypill in addition to other guideline-directed medical therapies prescribed by their physician. Polypill formulations will include rosuvastatin 40 mg, aspirin 81 mg, and prasugrel 10 mg daily or rosuvastatin 40 mg, aspirin 81 mg, and clopidogrel 75 mg.
Polypill: Polypill formulation consisting of rosuvastatin, aspirin, and prasugrel or consisting of rosuvastatin, aspirin, and clopidogrel.
|
Usual Care (Individual Medications Prescribed by Primary Cardiologist)
n=63 Participants
Patients will receive usual post-ACS care and medications prescribed by their provider. All of the individual components will be available at low- or no-cost to participants as individual pill formulations.
Usual Care (individual medications prescribed by primary cardiologist): Typical prescriptions for post-acute coronary syndrome care including statin, aspirin, and prasugrel or clopidogrel.
|
|---|---|---|
|
Adherence by Self-report
|
0.61 units on a scale
Interval 0.24 to 0.98
|
0.21 units on a scale
Interval -0.07 to 0.48
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Participants who presented to the 1 month follow-up.
Within group and between group change in treatment satisfaction by Treatment Satisfaction Questionnaire for Medicine. The score ranges from 0-100, with 100 indicating highest satisfaction, and 0 indicating lowest satisfaction. The two relevant time points included baseline and 1 month values.
Outcome measures
| Measure |
Polypill
n=65 Participants
Patients will be randomized to receiving a fixed-dose polypill in addition to other guideline-directed medical therapies prescribed by their physician. Polypill formulations will include rosuvastatin 40 mg, aspirin 81 mg, and prasugrel 10 mg daily or rosuvastatin 40 mg, aspirin 81 mg, and clopidogrel 75 mg.
Polypill: Polypill formulation consisting of rosuvastatin, aspirin, and prasugrel or consisting of rosuvastatin, aspirin, and clopidogrel.
|
Usual Care (Individual Medications Prescribed by Primary Cardiologist)
n=63 Participants
Patients will receive usual post-ACS care and medications prescribed by their provider. All of the individual components will be available at low- or no-cost to participants as individual pill formulations.
Usual Care (individual medications prescribed by primary cardiologist): Typical prescriptions for post-acute coronary syndrome care including statin, aspirin, and prasugrel or clopidogrel.
|
|---|---|---|
|
Treatment Satisfaction
|
1.81 units on a scale
Interval -3.17 to 6.8
|
0.65 units on a scale
Interval -4.26 to 5.56
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Participants who presented to the 1 month follow-up visit
Within group and between group difference in the Seattle Angina Questionnaire, which ranges from 0-100. 100 indicates best quality of life, 0 indicates worst quality of life. The two relevant time points included baseline and 1 month laboratory values.
Outcome measures
| Measure |
Polypill
n=65 Participants
Patients will be randomized to receiving a fixed-dose polypill in addition to other guideline-directed medical therapies prescribed by their physician. Polypill formulations will include rosuvastatin 40 mg, aspirin 81 mg, and prasugrel 10 mg daily or rosuvastatin 40 mg, aspirin 81 mg, and clopidogrel 75 mg.
Polypill: Polypill formulation consisting of rosuvastatin, aspirin, and prasugrel or consisting of rosuvastatin, aspirin, and clopidogrel.
|
Usual Care (Individual Medications Prescribed by Primary Cardiologist)
n=63 Participants
Patients will receive usual post-ACS care and medications prescribed by their provider. All of the individual components will be available at low- or no-cost to participants as individual pill formulations.
Usual Care (individual medications prescribed by primary cardiologist): Typical prescriptions for post-acute coronary syndrome care including statin, aspirin, and prasugrel or clopidogrel.
|
|---|---|---|
|
Quality of Life at 1 Month
|
8.18 units on a scale
Interval 3.95 to 12.4
|
5.08 units on a scale
Interval 0.32 to 9.84
|
Adverse Events
Polypill
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care (Individual Medications Prescribed by Primary Cardiologist)
Serious events: 8 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Polypill
n=69 participants at risk
Patients will be randomized to receiving a fixed-dose polypill in addition to other guideline-directed medical therapies prescribed by their physician. Polypill formulations will include rosuvastatin 40 mg, aspirin 81 mg, and prasugrel 10 mg daily or rosuvastatin 40 mg, aspirin 81 mg, and clopidogrel 75 mg.
Polypill: Polypill formulation consisting of rosuvastatin, aspirin, and prasugrel or consisting of rosuvastatin, aspirin, and clopidogrel.
|
Usual Care (Individual Medications Prescribed by Primary Cardiologist)
n=71 participants at risk
Patients will receive usual post-ACS care and medications prescribed by their provider. All of the individual components will be available at low- or no-cost to participants as individual pill formulations.
Usual Care (individual medications prescribed by primary cardiologist): Typical prescriptions for post-acute coronary syndrome care including statin, aspirin, and prasugrel or clopidogrel.
|
|---|---|---|
|
Blood and lymphatic system disorders
Total Hospitalizations and Emergency Department Visits
|
11.6%
8/69 • Number of events 10 • 1 month
1-month emergency department visits, all-cause hospitalizations, all-cause mortality were assessed. Additionally, specific AE of interest included percutaneous coronary intervention that was not scheduled. Adverse events were combined for both polypill subtypes in the usual care arm and in the polypill arm given both P2Y12 inhibitors (prasugrel or clopidogrel) are guideline-recommended for use after acute coronary syndrome.
|
11.3%
8/71 • Number of events 13 • 1 month
1-month emergency department visits, all-cause hospitalizations, all-cause mortality were assessed. Additionally, specific AE of interest included percutaneous coronary intervention that was not scheduled. Adverse events were combined for both polypill subtypes in the usual care arm and in the polypill arm given both P2Y12 inhibitors (prasugrel or clopidogrel) are guideline-recommended for use after acute coronary syndrome.
|
Other adverse events
| Measure |
Polypill
n=69 participants at risk
Patients will be randomized to receiving a fixed-dose polypill in addition to other guideline-directed medical therapies prescribed by their physician. Polypill formulations will include rosuvastatin 40 mg, aspirin 81 mg, and prasugrel 10 mg daily or rosuvastatin 40 mg, aspirin 81 mg, and clopidogrel 75 mg.
Polypill: Polypill formulation consisting of rosuvastatin, aspirin, and prasugrel or consisting of rosuvastatin, aspirin, and clopidogrel.
|
Usual Care (Individual Medications Prescribed by Primary Cardiologist)
n=71 participants at risk
Patients will receive usual post-ACS care and medications prescribed by their provider. All of the individual components will be available at low- or no-cost to participants as individual pill formulations.
Usual Care (individual medications prescribed by primary cardiologist): Typical prescriptions for post-acute coronary syndrome care including statin, aspirin, and prasugrel or clopidogrel.
|
|---|---|---|
|
Cardiac disorders
Non-elective percutaneous coronary intervention
|
0.00%
0/69 • 1 month
1-month emergency department visits, all-cause hospitalizations, all-cause mortality were assessed. Additionally, specific AE of interest included percutaneous coronary intervention that was not scheduled. Adverse events were combined for both polypill subtypes in the usual care arm and in the polypill arm given both P2Y12 inhibitors (prasugrel or clopidogrel) are guideline-recommended for use after acute coronary syndrome.
|
1.4%
1/71 • Number of events 1 • 1 month
1-month emergency department visits, all-cause hospitalizations, all-cause mortality were assessed. Additionally, specific AE of interest included percutaneous coronary intervention that was not scheduled. Adverse events were combined for both polypill subtypes in the usual care arm and in the polypill arm given both P2Y12 inhibitors (prasugrel or clopidogrel) are guideline-recommended for use after acute coronary syndrome.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place