Phase 4
Completed N=5,276
Tailored Antiplatelet Therapy Following PCI
Source: ClinicalTrials.gov NCT01742117 ↗Enrolled (actual)
5,276
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: Occurrence of the a Major Adverse Cardiovascular Event in Subjects Identified as CPY2C19 LOF Carriers by TaqMan. — 35; 54 Participants
◆ Published Evidence
Highly cited
404citations · ~67 / year
Effect of Genotype-Guided Oral P2Y12 Inhibitor Selection vs Conventional Clopidogrel Therapy on Ischemic Outcomes After Percutaneous Coronary Intervention: The TAILOR-PCI Randomized Clinical Trial.
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.
Linked Publications (5)
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Effect of Genotype-Guided Oral P2Y12 Inhibitor Selection vs Conventional Clopidogrel Therapy on Ischemic Outcomes After Percutaneous Coronary Intervention: The TAILOR-PCI Randomized Clinical Trial.
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Genetic-Guided Oral P2Y<sub>12</sub> Inhibitor Selection and Cumulative Ischemic Events After Percutaneous Coronary Intervention.
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Sex-Specific Differences in Clinical Outcomes After Percutaneous Coronary Intervention: Insights from the TAILOR-PCI Trial.
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Patient Onboarding and Engagement to Build a Digital Study After Enrollment in a Clinical Trial (TAILOR-PCI Digital Study): Intervention Study.
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Safety and Efficacy of CYP2C19 Genotype-Guided Escalation of P2Y<sub>12</sub> Inhibitor Therapy After Percutaneous Coronary Intervention in Chronic Kidney Disease: a Post Hoc Analysis of the TAILOR-PCI Study.
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 | — |
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.)
Data sourced from ClinicalTrials.gov (NCT01742117) and the linked publication. 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. Informational only — not medical advice.