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Tailored Antiplatelet Therapy Following PCI (TAILOR-PCI)
This study is currently recruiting participants.
Verified June 2016 by Naveen L. Pereira, Mayo Clinic
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
ClinicalTrials.gov Identifier:
NCT01742117
First received: December 3, 2012
Last updated: June 17, 2016
Last verified: June 2016
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| First Received Date ICMJE | December 3, 2012 | |||||||||
| Last Updated Date | June 17, 2016 | |||||||||
| Start Date ICMJE | May 2013 | |||||||||
| Estimated Primary Completion Date | September 2019 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Occurrence of the 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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| 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 | Complete list of historical versions of study NCT01742117 on ClinicalTrials.gov Archive Site | |||||||||
| Current 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 ] | |||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Outcome Measures ICMJE | Not Provided | |||||||||
| Original Other Outcome Measures ICMJE | 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 | Phase 4 | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Intervention ICMJE |
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| Publications * | Not Provided | |||||||||
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* 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 | Recruiting | |||||||||
| Estimated Enrollment ICMJE | 5270 | |||||||||
| Estimated Completion Date | March 2020 | |||||||||
| Estimated Primary Completion Date | September 2019 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion
5.3 Exclusion
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| Ages | 18 Years and older (Adult, Senior) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Canada, Korea, Republic of, United States | |||||||||
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| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT01742117 | |||||||||
| Other Study ID Numbers ICMJE | 11-006837 | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement | Not Provided | |||||||||
| Responsible Party | Naveen L. Pereira, Mayo Clinic | |||||||||
| Study Sponsor ICMJE | Mayo Clinic | |||||||||
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| PRS Account | Mayo Clinic | |||||||||
| Verification Date | June 2016 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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