Trial Outcomes & Findings for Tailored Antiplatelet Therapy Following PCI (NCT NCT01742117)
NCT ID: NCT01742117
Last Updated: 2021-11-09
Results Overview
Number of subjects who experienced major adverse cardiovascular event as defined as cardiovascular death, myocardial infarction, stroke, severe recurrent ischemia, and stent thrombosis in subjects identified as CPY2C19 LOF carriers by TaqMan.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
5276 participants
Primary outcome timeframe
1 year after percutaneous coronary intervention (PCI)
Results posted on
2021-11-09
Participant Flow
Participant milestones
| Measure |
Genotype-Guided Therapy
Subjects will be genotyped prospectively for CYP2C19\*2, \*3 and \*17 alleles and will receive treatment based on their genotype. In this group, patients who have the CYP2C19 reduced function allele \[i.e., \*2 allele (heterozygous or homozygous) or \*3 allele (heterozygous or homozygous)\] patients will receive ticagrelor 90 mg bid. The WT YP2C19 patients will receive clopidogrel 75 mg once daily.
Clopidogrel: One 75 mg tablet per day by mouth for one year
Ticagrelor: One 90 mg tablet twice per day by mouth for one year
|
Conventional Therapy
Subjects will receive clopidogrel once daily after the index PCI and will be retrospectively genotyped for CYP2C19\*2, \*3 and \*17 alleles after completion of one year of treatment with clopidogrel.
Clopidogrel: One 75 mg tablet per day by mouth for one year
|
|---|---|---|
|
Overall Study
STARTED
|
2641
|
2635
|
|
Overall Study
COMPLETED
|
2641
|
2635
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tailored Antiplatelet Therapy Following PCI
Baseline characteristics by cohort
| Measure |
Genotype-Guided Therapy
n=2641 Participants
Subjects will be genotyped prospectively for CYP2C19\*2, \*3 and \*17 alleles and will receive treatment based on their genotype. In this group, patients who have the CYP2C19 reduced function allele \[i.e., \*2 allele (heterozygous or homozygous) or \*3 allele (heterozygous or homozygous)\] patients will receive ticagrelor 90 mg bid. The WT YP2C19 patients will receive clopidogrel 75 mg once daily.
Clopidogrel: One 75 mg tablet per day by mouth for one year
Ticagrelor: One 90 mg tablet twice per day by mouth for one year
|
Conventional Therapy
n=2635 Participants
Subjects will receive clopidogrel once daily after the index PCI and will be retrospectively genotyped for CYP2C19\*2, \*3 and \*17 alleles after completion of one year of treatment with clopidogrel.
Clopidogrel: One 75 mg tablet per day by mouth for one year
|
Total
n=5276 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
62 years
n=7 Participants
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
648 Participants
n=5 Participants
|
645 Participants
n=7 Participants
|
1293 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1993 Participants
n=5 Participants
|
1990 Participants
n=7 Participants
|
3983 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1750 Participants
n=5 Participants
|
1754 Participants
n=7 Participants
|
3504 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
595 Participants
n=5 Participants
|
592 Participants
n=7 Participants
|
1187 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
South Asian
|
116 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
236 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African America
|
57 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other, Unknown or Not Reported
|
123 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
225 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latinx ethnicity
|
78 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
577 participants
n=5 Participants
|
580 participants
n=7 Participants
|
1157 participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
654 participants
n=5 Participants
|
650 participants
n=7 Participants
|
1304 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1359 participants
n=5 Participants
|
1358 participants
n=7 Participants
|
2717 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
51 participants
n=5 Participants
|
47 participants
n=7 Participants
|
98 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year after percutaneous coronary intervention (PCI)Population: For 1 year endpoint in Genotype-Guided Therapy arm 1738 were excluded from data analysis due Identified as CYP2C19 LOF noncarriers by TaqMan or no TaqMan results available. For 1 year endpoint in Conventional Therapy arm 1689 were excluded from data analysis due Identified as CYP2C19 LOF noncarriers by TaqMan or no TaqMan results available.
Number of subjects who experienced major adverse cardiovascular event as defined as cardiovascular death, myocardial infarction, stroke, severe recurrent ischemia, and stent thrombosis in subjects identified as CPY2C19 LOF carriers by TaqMan.
Outcome measures
| Measure |
Genotype-Guided Therapy
n=903 Participants
Subjects will be genotyped prospectively for CYP2C19\*2, \*3 and \*17 alleles and will receive treatment based on their genotype. In this group, patients who have the CYP2C19 reduced function allele \[i.e., \*2 allele (heterozygous or homozygous) or \*3 allele (heterozygous or homozygous)\] patients will receive ticagrelor 90 mg bid. The WT YP2C19 patients will receive clopidogrel 75 mg once daily.
Clopidogrel: One 75 mg tablet per day by mouth for one year
Ticagrelor: One 90 mg tablet twice per day by mouth for one year
|
Conventional Therapy
n=946 Participants
Subjects will receive clopidogrel once daily after the index PCI and will be retrospectively genotyped for CYP2C19\*2, \*3 and \*17 alleles after completion of one year of treatment with clopidogrel.
Clopidogrel: One 75 mg tablet per day by mouth for one year
|
|---|---|---|
|
Occurrence of the a Major Adverse Cardiovascular Event in Subjects Identified as CPY2C19 LOF Carriers by TaqMan.
|
35 Participants
|
54 Participants
|
PRIMARY outcome
Timeframe: Approximately 3 years after percutaneous coronary intervention (PCI)Number of subjects to experience a major adverse cardiovascular event as defined as cardiovascular death, myocardial infarction, stroke, severe recurrent ischemia, and stent thrombosis.
Outcome measures
| Measure |
Genotype-Guided Therapy
n=2641 Participants
Subjects will be genotyped prospectively for CYP2C19\*2, \*3 and \*17 alleles and will receive treatment based on their genotype. In this group, patients who have the CYP2C19 reduced function allele \[i.e., \*2 allele (heterozygous or homozygous) or \*3 allele (heterozygous or homozygous)\] patients will receive ticagrelor 90 mg bid. The WT YP2C19 patients will receive clopidogrel 75 mg once daily.
Clopidogrel: One 75 mg tablet per day by mouth for one year
Ticagrelor: One 90 mg tablet twice per day by mouth for one year
|
Conventional Therapy
n=2635 Participants
Subjects will receive clopidogrel once daily after the index PCI and will be retrospectively genotyped for CYP2C19\*2, \*3 and \*17 alleles after completion of one year of treatment with clopidogrel.
Clopidogrel: One 75 mg tablet per day by mouth for one year
|
|---|---|---|
|
Occurrence of the a Major Adverse Cardiovascular Event
|
262 Participants
|
269 Participants
|
SECONDARY outcome
Timeframe: 1 year after percutaneous coronary intervention (PCI)Population: For 1 year endpoint in Genotype-Guided Therapy arm 1738 were excluded from data analysis due Identified as CYP2C19 LOF noncarriers by TaqMan or no TaqMan results available. For 1 year endpoint in Conventional Therapy arm 1689 were excluded from data analysis due Identified as CYP2C19 LOF noncarriers by TaqMan or no TaqMan results available.
Number of subjects that experienced thrombolysis in myocardial infarction major or minor bleeding in subjects identified as CYP2C19 LOF carriers by TaqMan
Outcome measures
| Measure |
Genotype-Guided Therapy
n=903 Participants
Subjects will be genotyped prospectively for CYP2C19\*2, \*3 and \*17 alleles and will receive treatment based on their genotype. In this group, patients who have the CYP2C19 reduced function allele \[i.e., \*2 allele (heterozygous or homozygous) or \*3 allele (heterozygous or homozygous)\] patients will receive ticagrelor 90 mg bid. The WT YP2C19 patients will receive clopidogrel 75 mg once daily.
Clopidogrel: One 75 mg tablet per day by mouth for one year
Ticagrelor: One 90 mg tablet twice per day by mouth for one year
|
Conventional Therapy
n=946 Participants
Subjects will receive clopidogrel once daily after the index PCI and will be retrospectively genotyped for CYP2C19\*2, \*3 and \*17 alleles after completion of one year of treatment with clopidogrel.
Clopidogrel: One 75 mg tablet per day by mouth for one year
|
|---|---|---|
|
Thrombolysis in Myocardial Infarction Major or Minor Bleeding in Subjects Identified as CPY2C19 LOF Carriers by TaqMan.
|
16 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Approximately 3 years after percutaneous coronary intervention (PCI)Number of subjects that experienced thrombolysis in myocardial infarction major or minor bleeding
Outcome measures
| Measure |
Genotype-Guided Therapy
n=2641 Participants
Subjects will be genotyped prospectively for CYP2C19\*2, \*3 and \*17 alleles and will receive treatment based on their genotype. In this group, patients who have the CYP2C19 reduced function allele \[i.e., \*2 allele (heterozygous or homozygous) or \*3 allele (heterozygous or homozygous)\] patients will receive ticagrelor 90 mg bid. The WT YP2C19 patients will receive clopidogrel 75 mg once daily.
Clopidogrel: One 75 mg tablet per day by mouth for one year
Ticagrelor: One 90 mg tablet twice per day by mouth for one year
|
Conventional Therapy
n=2635 Participants
Subjects will receive clopidogrel once daily after the index PCI and will be retrospectively genotyped for CYP2C19\*2, \*3 and \*17 alleles after completion of one year of treatment with clopidogrel.
Clopidogrel: One 75 mg tablet per day by mouth for one year
|
|---|---|---|
|
Thrombolysis in Myocardial Infarction Major or Minor Bleeding
|
54 Participants
|
53 Participants
|
Adverse Events
Genotype-Guided Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 95 deaths
Conventional Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 98 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