Tailored Antiplatelet Therapy Following PCI (TAILOR-PCI)
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ClinicalTrials.gov Identifier: NCT01742117 |
Recruitment Status :
Active, not recruiting
First Posted : December 5, 2012
Last Update Posted : April 8, 2021
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Sponsor:
Mayo Clinic
Collaborators:
Spartan Bioscience Inc.
Applied Health Research Centre
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Naveen L. Pereira, Mayo Clinic
Tracking Information | ||||||||||
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First Submitted Date ICMJE | December 3, 2012 | |||||||||
First Posted Date ICMJE | December 5, 2012 | |||||||||
Last Update Posted Date | April 8, 2021 | |||||||||
Study Start Date ICMJE | May 2013 | |||||||||
Estimated Primary Completion Date | March 31, 2021 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
Occurrence of the a major adverse cardiovascular event (MACE) [ Time Frame: Two years after percutaneous coronary intervention (PCI) ] MACE will include non-fatal myocardial infarction, non-fatal stroke, cardiovascular mortality, severe recurrent ischemia, and stent thrombosis
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Original Primary Outcome Measures ICMJE |
Time to occurrence of the composite endpoint of a major adverse cardiovascular event (MACE) [ Time Frame: Randomization, one year after percutaneous coronary intervention (PCI) ] MACE will include non-fatal myocardial infarction, non-fatal stroke, cardiovascular mortality, severe recurrent ischemia, and stent thrombosis
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Change History | ||||||||||
Current Secondary Outcome Measures ICMJE |
Number of subjects with reduced function CYP2C19 allele(s) who have major or minor bleeding [ Time Frame: Two years after percutaneous coronary intervention (PCI) ] Includes subjects who have bleeding events
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Original Secondary Outcome Measures ICMJE |
Number of subjects with reduced function CYP2C19 allele(s) who have major or minor bleeding [ Time Frame: One year after PCI ] | |||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | Tailored Antiplatelet Therapy Following PCI | |||||||||
Official Title ICMJE | Tailored Antiplatelet Initiation to Lesson Outcomes Due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention (TAILOR-PCI) | |||||||||
Brief 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. | |||||||||
Detailed Description | TAILOR-PCI is a multi-site, open label, prospective, randomized trial testing the hypothesis that after percutaneous coronary intervention (PCI), using a genotyping strategy ticagrelor 90 mg twice per day is superior to clopidogrel 75 mg per day in reducing a composite endpoint of major adverse cardiovascular events (MACE), i.e., non-fatal myocardial infarction, non-fatal stroke, severe recurrent ischemia, cardiovascular (CV) death, and stent thrombosis (primary endpoints) in CYP2C19 reduced function allele patients. Patients who undergo PCI will be randomized to a conventional therapy arm (i.e., to receive clopidogrel 75 mg once daily without prospective genotyping guidance) versus a prospective CYP2C19 genotype-based anti-platelet therapy approach (ticagrelor 90 mg bid in CYP2C19 *2 or *3 reduced function allele patients, clopidogrel 75 mg once daily in non-*2 or -*3 CYP2C19 patients). Buccal swabs will be obtained for those subjects randomized to the prospective genotyping arm. All subjects will have a blood sample drawn for DNA analysis but genotyping using these DNA samples will be performed only after completion of the duration of anti-platelet therapy (i.e., after one year). The primary endpoints will be assessed prospectively and will be compared between the conventional arm and the prospective genotyping arm among those identified as reduced function CYP2C19 allele carriers according to the 1-year genotype results. | |||||||||
Study Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Phase 4 | |||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Pereira NL, Farkouh ME, So D, Lennon R, Geller N, Mathew V, Bell M, Bae JH, Jeong MH, Chavez I, Gordon P, Abbott JD, Cagin C, Baudhuin L, Fu YP, Goodman SG, Hasan A, Iturriaga E, Lerman A, Sidhu M, Tanguay JF, Wang L, Weinshilboum R, Welsh R, Rosenberg Y, Bailey K, Rihal C. 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. JAMA. 2020 Aug 25;324(8):761-771. doi: 10.1001/jama.2020.12443. | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||
Recruitment Status ICMJE | Active, not recruiting | |||||||||
Actual Enrollment ICMJE |
5300 | |||||||||
Original Estimated Enrollment ICMJE |
5945 | |||||||||
Estimated Study Completion Date ICMJE | March 31, 2021 | |||||||||
Estimated Primary Completion Date | March 31, 2021 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE | Inclusion
5.3 Exclusion
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries ICMJE | Canada, Korea, Republic of, Mexico, United States | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT01742117 | |||||||||
Other Study ID Numbers ICMJE | 11-006837 5U01HL128606 ( U.S. NIH Grant/Contract ) 3U01HL128606-03S1 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | |||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | |||||||||
Responsible Party | Naveen L. Pereira, Mayo Clinic | |||||||||
Study Sponsor ICMJE | Mayo Clinic | |||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Mayo Clinic | |||||||||
Verification Date | April 2021 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |