Phase 4 N=5,276 Randomized Treatment

Tailored Antiplatelet Therapy Following PCI

Coronary Artery Disease · Acute Coronary Syndrome · Stenosis

Bottom Line

View on ClinicalTrials.gov: NCT01742117 ↗

Enrolled (actual)

5,276

Serious AEs

0.0%

Results posted

Nov 2021

Primary outcome: Primary: Occurrence of the a Major Adverse Cardiovascular Event in Subjects Identified as CPY2C19 LOF Carriers by TaqMan. — 35; 54 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Clopidogrel (Drug); Ticagrelor (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Oct 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Occurrence of the a Major Adverse Cardiovascular Event in Subjects Identified as CPY2C19 LOF Carriers by TaqMan.	35; 54	—
PRIMARY Occurrence of the a Major Adverse Cardiovascular Event	262; 269	—
SECONDARY Thrombolysis in Myocardial Infarction Major or Minor Bleeding in Subjects Identified as CPY2C19 LOF Carriers by TaqMan.	16; 14	—
SECONDARY Thrombolysis in Myocardial Infarction Major or Minor Bleeding	54; 53	—

Summary

Clopidogrel is an anti-platelet medication approved by the U.S. Federal Drug Administration (FDA) for use in patients who undergo Percutaneous Coronary Intervention (PCI) with coronary stent implantation. Anti-platelet medications work to prevent blood clots from forming. Some studies have suggested that patients who have a certain genetic liver enzyme abnormality (known as cytochrome P450 2C19 [CYP2C19] *2 or *3 allele) may have a reduced ability to activate clopidogrel, and therefore may have a lowered response to clopidogrel. It is thought that perhaps people who have a coronary stent procedure may have this genetic liver enzyme abnormality. There is a research genetic test available to determine whether or not someone has this genetic liver enzyme abnormality. Ticagrelor, is a newer anti-platelet drug that is not dependent on the CYP2C19 liver enzyme for its activation and hence in poor clopidogrel metabolizers, alternative drugs like Ticagrelor have been recommended for use as an anti-platelet agent after PCI. The purpose of this study is to determine if genetic testing can identify the best anti-platelet therapy, for patients who undergo a coronary stent placement and do not activate clopidogrel very well.

Eligibility Criteria

Inclusion

Patient >18 years of age
Patient presents with acute coronary syndrome (ACS) or stable coronary artery disease (CAD)
Patient is eligible for PCI
Patient is willing and able to provide informed written consent

5.3 Exclusion

Patient not able to receive 12 months of dual anti-platelet therapy
Failure of index PCI
Patient or physician refusal to enroll in the study
Patient with known CYP2C19 genotype prior to randomization
Planned revascularization of any vessel within 30 days post-index procedure and/or of the target vessel(s) within 12 months post-procedure
Anticipated discontinuation of clopidogrel or ticagrelor within the 12 month follow up period, example for elective surgery
Serum creatinine >2.5 mg/dL within 7 days of index procedure
Platelet count 700, 000 cells/mm3, or white blood cell count 40 mg qd
Concomitant use of potent CYP3A4 inhibitors (atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) or inducers (carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin, and rifapentine)
Non-cardiac condition limiting life expectancy to less than one year, per physician judgment (e.g. cancer)
Known history of severe hepatic impairment
Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
Patient has an active pathological bleeding, such as active gastrointestinal (GI) bleeding
Inability to take aspirin at a dosage of 100 mg or less
Current substance abuse (e.g., alcohol, cocaine, heroin, etc.)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01742117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.