Tailored Antiplatelet Therapy Following PCI (TAILOR-PCI)
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ClinicalTrials.gov Identifier: NCT01742117 |
Recruitment Status :
Completed
First Posted : December 5, 2012
Results First Posted : November 9, 2021
Last Update Posted : November 9, 2021
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Condition or disease | Intervention/treatment | Phase |
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Coronary Artery Disease Acute Coronary Syndrome Stenosis | Drug: Clopidogrel Drug: Ticagrelor | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 5276 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Tailored Antiplatelet Initiation to Lesson Outcomes Due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention (TAILOR-PCI) |
Study Start Date : | May 2013 |
Actual Primary Completion Date : | October 31, 2020 |
Actual Study Completion Date : | October 31, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: 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.
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Drug: Clopidogrel
One 75 mg tablet per day by mouth for one year
Other Name: Plavix Drug: Ticagrelor One 90 mg tablet twice per day by mouth for one year
Other Name: Brilinta |
Active Comparator: 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.
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Drug: Clopidogrel
One 75 mg tablet per day by mouth for one year
Other Name: Plavix |
- Occurrence of the a Major Adverse Cardiovascular Event in Subjects Identified as CPY2C19 LOF Carriers by TaqMan. [ Time Frame: 1 year after percutaneous coronary intervention (PCI) ]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.
- Occurrence of the a Major Adverse Cardiovascular Event [ Time Frame: 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.
- Thrombolysis in Myocardial Infarction Major or Minor Bleeding in Subjects Identified as CPY2C19 LOF Carriers by TaqMan. [ Time Frame: 1 year after percutaneous coronary intervention (PCI) ]Number of subjects that experienced thrombolysis in myocardial infarction major or minor bleeding in subjects identified as CYP2C19 LOF carriers by TaqMan
- Thrombolysis in Myocardial Infarction Major or Minor Bleeding [ Time Frame: Approximately 3 years after percutaneous coronary intervention (PCI) ]Number of subjects that experienced thrombolysis in myocardial infarction major or minor bleeding

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 <80,000 or >700,000 cells/mm3, or white blood cell count <3,000 cells/mm3 if persistent (at least 2 abnormal values) within 7 days prior to index procedure.
- History of intracranial hemorrhage
- Known hypersensitivity to clopidogrel or ticagrelor or any of its components
- Patient is participating in an investigational drug or device clinical trial that has not reached its primary endpoint
- Patient previously enrolled in this study
- Patient is pregnant, lactating, or planning to become pregnant within 12 months
- Patient has received an organ transplant or is on a waiting list for an organ transplant
- Patient is receiving or scheduled to receive chemotherapy within 30 days before or after the procedure
- Patient is receiving immunosuppressive therapy or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematous, etc.)
- Patient is receiving chronic oral anticoagulation therapy (i.e., vitamin K antagonist, direct thrombin inhibitor, Factor Xa inhibitor)
- Concomitant use of simvastatin/lovastatin > 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.)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01742117

Principal Investigator: | Naveen Pereira, MD | Mayo Clinic | |
Principal Investigator: | Michael E Farkouh, MD | Toronto General Hospital | |
Principal Investigator: | Kent R Bailey, PhD | Mayo Clinic |
Documents provided by Naveen L. Pereira, Mayo Clinic:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Naveen L. Pereira, Professor of Medicine, College of Medicine, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT01742117 |
Other Study ID Numbers: |
11-006837 5U01HL128606 ( U.S. NIH Grant/Contract ) 3U01HL128606-03S1 ( U.S. NIH Grant/Contract ) |
First Posted: | December 5, 2012 Key Record Dates |
Results First Posted: | November 9, 2021 |
Last Update Posted: | November 9, 2021 |
Last Verified: | October 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
percutaneous coronary intervention angioplasty |
Coronary Artery Disease Acute Coronary Syndrome Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Clopidogrel |
Ticagrelor Platelet Aggregation Inhibitors Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |