Trial Outcomes & Findings for Pharmacogenomics of Anti-platelet Intervention-2 (PAPI-2) Study (NCT NCT01452152)
NCT ID: NCT01452152
Last Updated: 2022-03-16
Results Overview
Cardiovascular events include non-fatal myocardial infarction, non-fatal stroke, definite or probable stent thrombosis (ARC definition) and death secondary to any cardiovascular cause.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
9 participants
Primary outcome timeframe
One year
Results posted on
2022-03-16
Participant Flow
Participant milestones
| Measure |
Genotype-directed, Clopidogrel
Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.
clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year
|
Genotype-directed, Prasugrel
Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.
prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year
|
Standard of Care
Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
0
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
4
|
Reasons for withdrawal
| Measure |
Genotype-directed, Clopidogrel
Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.
clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year
|
Genotype-directed, Prasugrel
Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.
prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year
|
Standard of Care
Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
|
|---|---|---|---|
|
Overall Study
Study termination by sponsor
|
5
|
0
|
4
|
Baseline Characteristics
Pharmacogenomics of Anti-platelet Intervention-2 (PAPI-2) Study
Baseline characteristics by cohort
| Measure |
Genotype-directed, Clopidogrel
n=5 Participants
Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.
clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year
|
Genotype-directed, Prasugrel
Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.
prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year
|
Standard of Care
n=4 Participants
Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
—
|
3 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
—
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
—
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
—
|
2 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
—
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=93 Participants
|
—
|
3 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
—
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
—
|
2 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
—
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: One yearPopulation: Zero participants were assigned to genotype-directed, prasugrel group
Cardiovascular events include non-fatal myocardial infarction, non-fatal stroke, definite or probable stent thrombosis (ARC definition) and death secondary to any cardiovascular cause.
Outcome measures
| Measure |
Genotype-directed, Clopidogrel
n=5 Participants
Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.
clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year
|
Genotype-directed, Prasugrel
Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.
prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year
|
Standard of Care
n=4 Participants
Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
|
|---|---|---|---|
|
Occurrence of Post-randomization Cardiovascular Events
|
0 participants
|
—
|
0 participants
|
SECONDARY outcome
Timeframe: One yearPopulation: Zero participants were assigned to genotype-directed, prasugrel group
Bleeding events will classified by the Bleeding Academic Research Consortium definition. The number of bleeding events will be tabulated.
Outcome measures
| Measure |
Genotype-directed, Clopidogrel
n=5 Participants
Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.
clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year
|
Genotype-directed, Prasugrel
Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.
prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year
|
Standard of Care
n=4 Participants
Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
|
|---|---|---|---|
|
Occurrence of Bleeding Events
|
0 events
|
—
|
0 events
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Optional platelet aggregation was performed in 3 of 5 participants randomized to the Genotype-directed, clopidogrel arm and 0 of 4 participants randomized to the Standard of Care arm.
Platelet aggregation will be performed on a subset of subjects using VerifyNow P2Y12 which measures platelet reactivity due to the effect of a P2Y12. Values less than 180 P2Y12 Reaction Units (PRU) suggest evidence of a P2Y12 inhibitor effect. Platelet aggregation studies are optional and will not be used to modulate antiplatelet therapy.
Outcome measures
| Measure |
Genotype-directed, Clopidogrel
n=3 Participants
Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.
clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year
|
Genotype-directed, Prasugrel
Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.
prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year
|
Standard of Care
Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
|
|---|---|---|---|
|
Post-treatment Platelet Aggregation
|
33.7 percentage of inhibition
Standard Deviation 18.5
|
—
|
—
|
SECONDARY outcome
Timeframe: One yearPopulation: This outcome measure has zero total participants analyzed because health care resource utilization and cost-effectiveness data was not collected due to the early termination of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One yearPopulation: Zero participants were assigned to the genotype-directed, prasugrel group
The number of subjects reporting any AEs will be tabulated.
Outcome measures
| Measure |
Genotype-directed, Clopidogrel
n=5 Participants
Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.
clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year
|
Genotype-directed, Prasugrel
Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.
prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year
|
Standard of Care
n=4 Participants
Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
|
|---|---|---|---|
|
Occurrence of Adverse Events
|
1 participants
|
—
|
3 participants
|
SECONDARY outcome
Timeframe: One yearPopulation: Zero participants were assigned to genotype-directed, prasugrel group
Outcome measures
| Measure |
Genotype-directed, Clopidogrel
n=5 Participants
Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.
clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year
|
Genotype-directed, Prasugrel
Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.
prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year
|
Standard of Care
n=4 Participants
Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
|
|---|---|---|---|
|
Composite of All-cause Death, Myocardial Infarction (MI), Stroke and Repeat Revascularization
|
0 participants
|
—
|
0 participants
|
Adverse Events
Genotype-directed, Clopidogrel
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Genotype-directed, Prasugrel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Genotype-directed, Clopidogrel
n=5 participants at risk
Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.
clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year
|
Genotype-directed, Prasugrel
Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.
prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year
|
Standard of Care
n=4 participants at risk
Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
|
|---|---|---|---|
|
Cardiac disorders
chest pain - cardiac
|
0.00%
0/5 • One year
Zero participants were assigned to genotype-directed, prasugrel group
|
—
0/0 • One year
Zero participants were assigned to genotype-directed, prasugrel group
|
25.0%
1/4 • Number of events 1 • One year
Zero participants were assigned to genotype-directed, prasugrel group
|
Other adverse events
| Measure |
Genotype-directed, Clopidogrel
n=5 participants at risk
Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.
clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year
|
Genotype-directed, Prasugrel
Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.
prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year
|
Standard of Care
n=4 participants at risk
Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
|
|---|---|---|---|
|
Gastrointestinal disorders
gastritis
|
0.00%
0/5 • One year
Zero participants were assigned to genotype-directed, prasugrel group
|
—
0/0 • One year
Zero participants were assigned to genotype-directed, prasugrel group
|
25.0%
1/4 • Number of events 1 • One year
Zero participants were assigned to genotype-directed, prasugrel group
|
|
Infections and infestations
hepatitis viral
|
0.00%
0/5 • One year
Zero participants were assigned to genotype-directed, prasugrel group
|
—
0/0 • One year
Zero participants were assigned to genotype-directed, prasugrel group
|
25.0%
1/4 • Number of events 1 • One year
Zero participants were assigned to genotype-directed, prasugrel group
|
|
Cardiac disorders
atrial fibrillation
|
20.0%
1/5 • Number of events 1 • One year
Zero participants were assigned to genotype-directed, prasugrel group
|
—
0/0 • One year
Zero participants were assigned to genotype-directed, prasugrel group
|
0.00%
0/4 • One year
Zero participants were assigned to genotype-directed, prasugrel group
|
Additional Information
Dr. Alan R. Shuldiner
University of Maryland School of Medicine
Phone: 410-706-1623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place