Trial Outcomes & Findings for Antiplatelet Therapy Guided by Thrombelastography in Patients With Acute Coronary Syndromes (TEGCOR Study) (NCT NCT01612884)
NCT ID: NCT01612884
Last Updated: 2018-04-26
Results Overview
Persistence of high tensile clot strength measured by TEG 16-24 hours after reloading of either clopidogrel or prasugrel
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
67 participants
Primary outcome timeframe
1 day
Results posted on
2018-04-26
Participant Flow
67 subjects were enrolled and underwent testing on day 0. Only 37 of those subjects underwent PCI, and therefore were randomized to either LTA or TEG guided intervention arm. The remainder of subjects were treated medically without PCI or were referred for CABG (see flow diagram in protocol) and did not get randomized to any intervention arm.
Participant milestones
| Measure |
Thrombelastography (TEG) Guided
Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA\<69
Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder
Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder
|
Light Transmittance Aggregometry Guided
Clopidogrel non-response defined as MPA ADP \>42.9% Clopidogrel response defined as MPA ADP \<42.9%
Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder
Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
18
|
|
Overall Study
COMPLETED
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Antiplatelet Therapy Guided by Thrombelastography in Patients With Acute Coronary Syndromes (TEGCOR Study)
Baseline characteristics by cohort
| Measure |
Total
n=37 Participants
Total of all reporting groups
|
Thrombelastography (TEG) Guided
n=19 Participants
Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA\<69
Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder
Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder
|
Light Transmittance Aggregometry Guided
n=18 Participants
Clopidogrel non-response defined as MPA ADP \>42.9% Clopidogrel response defined as MPA ADP \<42.9%
Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder
Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder
|
|---|---|---|---|
|
Age, Continuous
|
54.2 years
STANDARD_DEVIATION 10 • n=206 Participants
|
55.2 years
STANDARD_DEVIATION 9.8 • n=99 Participants
|
53.2 years
STANDARD_DEVIATION 10.5 • n=107 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=206 Participants
|
5 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=206 Participants
|
14 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=206 Participants
|
14 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=206 Participants
|
5 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=206 Participants
|
19 participants
n=99 Participants
|
18 participants
n=107 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: TEG-MA (mm) at 16-24 hours outcome measure
Persistence of high tensile clot strength measured by TEG 16-24 hours after reloading of either clopidogrel or prasugrel
Outcome measures
| Measure |
Thrombelastography (TEG) Guided
n=19 Participants
Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA\<69
Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder
Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder
|
Light Transmittance Aggregometry Guided
n=18 Participants
Clopidogrel non-response defined as MPA ADP \>42.9% Clopidogrel response defined as MPA ADP \<42.9%
Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder
Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder
|
|---|---|---|
|
Thrombelastography (TEG) MA
|
66.4 mm
Standard Deviation 11
|
65.8 mm
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: 6 monthsDeath, recurrent myocardial infarction, recurrent unstable angina, repeat coronary intervention
Outcome measures
| Measure |
Thrombelastography (TEG) Guided
n=19 Participants
Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA\<69
Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder
Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder
|
Light Transmittance Aggregometry Guided
n=18 Participants
Clopidogrel non-response defined as MPA ADP \>42.9% Clopidogrel response defined as MPA ADP \<42.9%
Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder
Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder
|
|---|---|---|
|
Number of Participants With Ischemic Events
Death · Event
|
0 Participants
|
0 Participants
|
|
Number of Participants With Ischemic Events
Death · No Event
|
19 Participants
|
18 Participants
|
|
Number of Participants With Ischemic Events
Myocardial Infarction · Event
|
1 Participants
|
0 Participants
|
|
Number of Participants With Ischemic Events
Myocardial Infarction · No Event
|
18 Participants
|
18 Participants
|
|
Number of Participants With Ischemic Events
Recurrent coronary intervention · Event
|
3 Participants
|
2 Participants
|
|
Number of Participants With Ischemic Events
Recurrent coronary intervention · No Event
|
16 Participants
|
16 Participants
|
|
Number of Participants With Ischemic Events
Unstable Angina · Event
|
2 Participants
|
2 Participants
|
|
Number of Participants With Ischemic Events
Unstable Angina · No Event
|
17 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 6 monthsMajor or Minor Bleeding according to TIMI criteria
Outcome measures
| Measure |
Thrombelastography (TEG) Guided
n=19 Participants
Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA\<69
Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder
Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder
|
Light Transmittance Aggregometry Guided
n=18 Participants
Clopidogrel non-response defined as MPA ADP \>42.9% Clopidogrel response defined as MPA ADP \<42.9%
Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder
Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder
|
|---|---|---|
|
Number of Participants With Bleeding Events
No Bleeding
|
19 Participants
|
18 Participants
|
|
Number of Participants With Bleeding Events
Bleeding
|
0 Participants
|
0 Participants
|
Adverse Events
Thrombelastography (TEG) Guided
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Light Transmittance Aggregometry Guided
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place