Trial Outcomes & Findings for Ticagrelor Administered as Standard Tablet or Orodispersible Formulation (NCT NCT03822377)
NCT ID: NCT03822377
Last Updated: 2021-09-08
Results Overview
Platelet reactivity will be measured by VerifyNow test 1 hour after Ticagrelor loading dose (LD) administered as orodispersible tablets as compared with standard formulation in 130 patients with STEMI or very high-risk NSTEMI undergoing immediate PCI. The VerifyNow PRU Test is designed to measure P2Y12 receptor blockade. Results of the PRU Tests are reported as P2Y12 Reaction Units (PRU). PRU measures the extent of platelet aggregation in the presence of a P2Y12 inhibitor. Lower PRU levels are associated with expected antiplatelet effect.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
130 participants
Primary outcome timeframe
1 hour
Results posted on
2021-09-08
Participant Flow
Participant milestones
| Measure |
Ticagrelor Orodispersible Tablets
STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as orodispersible tablets.
Intervention: administration of Ticagrelor 180 mg loading dose as orodispersible tablets.
Ticagrelor orodispersible tablets: Ticagrelor loading dose (180 mg) given as two orodispersible tablets (each of 90 mg), to be dispersed in saliva.
|
Ticagrelor Standard Tablets
STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as standard coated tablets.
Intervention: administration of Ticagrelor 180 mg loading dose as standard coated pills.
Ticagrelor pills: Ticagrelor loading dose (180 mg) given as two standard coated tablets (each of 90 mg) to be swallowed with water.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
65
|
|
Overall Study
COMPLETED
|
65
|
65
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ticagrelor Administered as Standard Tablet or Orodispersible Formulation
Baseline characteristics by cohort
| Measure |
Ticagrelor Orodispersible Tablets
n=65 Participants
STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as orodispersible tablets.
Intervention: administration of Ticagrelor 180 mg loading dose as orodispersible tablets.
Ticagrelor orodispersible tablets: Ticagrelor loading dose (180 mg) given as two orodispersible tablets (each of 90 mg), to be dispersed in saliva.
|
Ticagrelor Standard Tablets
n=65 Participants
STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as standard coated tablets.
Intervention: administration of Ticagrelor 180 mg loading dose as standard coated pills.
Ticagrelor pills: Ticagrelor loading dose (180 mg) given as two standard coated tablets (each of 90 mg) to be swallowed with water.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 10.0 • n=99 Participants
|
63.0 years
STANDARD_DEVIATION 10.0 • n=107 Participants
|
63.5 years
STANDARD_DEVIATION 10.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
105 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
130 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 hourPlatelet reactivity will be measured by VerifyNow test 1 hour after Ticagrelor loading dose (LD) administered as orodispersible tablets as compared with standard formulation in 130 patients with STEMI or very high-risk NSTEMI undergoing immediate PCI. The VerifyNow PRU Test is designed to measure P2Y12 receptor blockade. Results of the PRU Tests are reported as P2Y12 Reaction Units (PRU). PRU measures the extent of platelet aggregation in the presence of a P2Y12 inhibitor. Lower PRU levels are associated with expected antiplatelet effect.
Outcome measures
| Measure |
Ticagrelor Orodispersible Tablets
n=65 Participants
STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as orodispersible tablets.
Intervention: administration of Ticagrelor 180 mg loading dose as orodispersible tablets.
Ticagrelor orodispersible tablets: Ticagrelor loading dose (180 mg) given as two orodispersible tablets (each of 90 mg), to be dispersed in saliva.
|
Ticagrelor Standard Tablets
n=65 Participants
STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as standard coated tablets.
Intervention: administration of Ticagrelor 180 mg loading dose as standard coated pills.
Ticagrelor pills: Ticagrelor loading dose (180 mg) given as two standard coated tablets (each of 90 mg) to be swallowed with water.
|
|---|---|---|
|
Evaluation of Platelet Inhibition
|
94 P2Y12 Reaction Units (PRU)
Interval 35.0 to 193.0
|
141 P2Y12 Reaction Units (PRU)
Interval 8.0 to 197.0
|
SECONDARY outcome
Timeframe: 1 hourThe percent of patients with a high residual platelet reactivity (PRU \> 208 by VerifyNow test), thus not adequately antiaggregated, 1 hour after Ticagrelor LD.
Outcome measures
| Measure |
Ticagrelor Orodispersible Tablets
n=65 Participants
STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as orodispersible tablets.
Intervention: administration of Ticagrelor 180 mg loading dose as orodispersible tablets.
Ticagrelor orodispersible tablets: Ticagrelor loading dose (180 mg) given as two orodispersible tablets (each of 90 mg), to be dispersed in saliva.
|
Ticagrelor Standard Tablets
n=65 Participants
STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as standard coated tablets.
Intervention: administration of Ticagrelor 180 mg loading dose as standard coated pills.
Ticagrelor pills: Ticagrelor loading dose (180 mg) given as two standard coated tablets (each of 90 mg) to be swallowed with water.
|
|---|---|---|
|
Percent of Patients With Insufficient Antiaggregation
|
51 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: 2, 4 and 6 hoursResidual platelet reactivity (PRU) at 2, 4 and 6 hours measured by VerifyNow test to assess antiplatelet effect of P2Y12 inhibitors
Outcome measures
| Measure |
Ticagrelor Orodispersible Tablets
n=65 Participants
STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as orodispersible tablets.
Intervention: administration of Ticagrelor 180 mg loading dose as orodispersible tablets.
Ticagrelor orodispersible tablets: Ticagrelor loading dose (180 mg) given as two orodispersible tablets (each of 90 mg), to be dispersed in saliva.
|
Ticagrelor Standard Tablets
n=65 Participants
STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as standard coated tablets.
Intervention: administration of Ticagrelor 180 mg loading dose as standard coated pills.
Ticagrelor pills: Ticagrelor loading dose (180 mg) given as two standard coated tablets (each of 90 mg) to be swallowed with water.
|
|---|---|---|
|
Number of Participants With Residual Platelet Reactivity at Various Timepoints
|
42 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 30 daysActionable bleeding events across the two different regimens of Ticagrelor administration, requiring diagnostic studies, hospitalization, or treatment by a health care professional (BARC type 2 or higher)
Outcome measures
| Measure |
Ticagrelor Orodispersible Tablets
n=65 Participants
STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as orodispersible tablets.
Intervention: administration of Ticagrelor 180 mg loading dose as orodispersible tablets.
Ticagrelor orodispersible tablets: Ticagrelor loading dose (180 mg) given as two orodispersible tablets (each of 90 mg), to be dispersed in saliva.
|
Ticagrelor Standard Tablets
n=65 Participants
STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as standard coated tablets.
Intervention: administration of Ticagrelor 180 mg loading dose as standard coated pills.
Ticagrelor pills: Ticagrelor loading dose (180 mg) given as two standard coated tablets (each of 90 mg) to be swallowed with water.
|
|---|---|---|
|
Number of Participants With Clinically Relevant Bleeding Events
|
0 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 hoursPotential morphine-ticagrelor interaction will be assessed by stratified randomization according to morphine use
Outcome measures
| Measure |
Ticagrelor Orodispersible Tablets
n=65 Participants
STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as orodispersible tablets.
Intervention: administration of Ticagrelor 180 mg loading dose as orodispersible tablets.
Ticagrelor orodispersible tablets: Ticagrelor loading dose (180 mg) given as two orodispersible tablets (each of 90 mg), to be dispersed in saliva.
|
Ticagrelor Standard Tablets
n=65 Participants
STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as standard coated tablets.
Intervention: administration of Ticagrelor 180 mg loading dose as standard coated pills.
Ticagrelor pills: Ticagrelor loading dose (180 mg) given as two standard coated tablets (each of 90 mg) to be swallowed with water.
|
|---|---|---|
|
Number of Participants With Morphine-ticagrelor Interaction
|
6 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Until discharge from the hospital (usually up to 7 days)Combined ticagrelor administration-related adverse events defined as in-hospital ≥2 BARC bleedings, dyspnea, ventricular pauses, allergic reactions, or vomit
Outcome measures
| Measure |
Ticagrelor Orodispersible Tablets
n=65 Participants
STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as orodispersible tablets.
Intervention: administration of Ticagrelor 180 mg loading dose as orodispersible tablets.
Ticagrelor orodispersible tablets: Ticagrelor loading dose (180 mg) given as two orodispersible tablets (each of 90 mg), to be dispersed in saliva.
|
Ticagrelor Standard Tablets
n=65 Participants
STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as standard coated tablets.
Intervention: administration of Ticagrelor 180 mg loading dose as standard coated pills.
Ticagrelor pills: Ticagrelor loading dose (180 mg) given as two standard coated tablets (each of 90 mg) to be swallowed with water.
|
|---|---|---|
|
Incidence of Adverse Events Occurring During Hospital Stay
|
14 Participants
|
15 Participants
|
Adverse Events
Ticagrelor Orodispersible Tablets
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Ticagrelor Standard Tablets
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ticagrelor Orodispersible Tablets
n=65 participants at risk
STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as orodispersible tablets.
Intervention: administration of Ticagrelor 180 mg loading dose as orodispersible tablets.
Ticagrelor orodispersible tablets: Ticagrelor loading dose (180 mg) given as two orodispersible tablets (each of 90 mg), to be dispersed in saliva.
|
Ticagrelor Standard Tablets
n=65 participants at risk
STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as standard coated tablets.
Intervention: administration of Ticagrelor 180 mg loading dose as standard coated pills.
Ticagrelor pills: Ticagrelor loading dose (180 mg) given as two standard coated tablets (each of 90 mg) to be swallowed with water.
|
|---|---|---|
|
Cardiac disorders
Reinfarction
|
1.5%
1/65 • 30 days
|
0.00%
0/65 • 30 days
|
Other adverse events
| Measure |
Ticagrelor Orodispersible Tablets
n=65 participants at risk
STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as orodispersible tablets.
Intervention: administration of Ticagrelor 180 mg loading dose as orodispersible tablets.
Ticagrelor orodispersible tablets: Ticagrelor loading dose (180 mg) given as two orodispersible tablets (each of 90 mg), to be dispersed in saliva.
|
Ticagrelor Standard Tablets
n=65 participants at risk
STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as standard coated tablets.
Intervention: administration of Ticagrelor 180 mg loading dose as standard coated pills.
Ticagrelor pills: Ticagrelor loading dose (180 mg) given as two standard coated tablets (each of 90 mg) to be swallowed with water.
|
|---|---|---|
|
Cardiac disorders
Combined ticagrelor administration-related adverse events defined as in-hospital ≥2 BARC bleedings,
|
21.5%
14/65 • 30 days
|
23.1%
15/65 • 30 days
|
Additional Information
Prof. Guido Parodi
Cardiology Clinic, Sassari University Hospital, Sassari, Italy
Phone: 0039
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place