Coronary Artery Disease Clinical Trial
— TAILOR-PCIOfficial title:
Tailored Antiplatelet Initiation to Lesson Outcomes Due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention (TAILOR-PCI)
Verified date | October 2021 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5276 |
Est. completion date | October 31, 2020 |
Est. primary completion date | October 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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.) |
Country | Name | City | State |
---|---|---|---|
Canada | University of Ottawa Heart Institute | Ottawa | Ontario |
Canada | Regina General Hospital | Regina | Saskatchawan |
Canada | Thunder Bay Regional Health Sciences Centre | Thunder Bay | Ontario |
Canada | Humber River Hospital | Toronto | Ontario |
Canada | St Michael's Hospital | Toronto | Ontario |
Canada | Sunnybrook Health Services Center | Toronto | Ontario |
Canada | Toronto General Hospital - UHN | Toronto | Ontario |
Canada | Vancouver General Hospital, UBC Division of Cardiology | Vancouver | British Columbia |
Korea, Republic of | Konyang University College of Medicine | Daejeon | |
Korea, Republic of | Chonnam National University Hospital | Gwangju | |
Korea, Republic of | Ajou University Hospital | Gyeonggi-do | |
Korea, Republic of | Chung-Ang University Hospital | Seoul | |
Mexico | Hospital de Cardiologia, Centro Medico Nacional Siglo XXI | Mexico City | |
Mexico | Hospital de Especialidades, Centro Medico Nacional 'La Raza' | Mexico City | |
Mexico | Hospital REgional No. 1 | Mexico City | |
United States | Albany Medical College | Albany | New York |
United States | St. Elizabeth Healthcare | Crestview Hills | Kentucky |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Essentia Institute of Rural Health | Duluth | Minnesota |
United States | MHS, Eau Claire | Eau Claire | Wisconsin |
United States | NorthShore University Health System | Evanston | Illinois |
United States | Greenville Health System | Greenville | South Carolina |
United States | The University of Mississippi Medical Center | Jackson | Mississippi |
United States | Mayo Clinic in Florida | Jacksonville | Florida |
United States | Mayo Clinic Health System | La Crosse | Wisconsin |
United States | The Feinstein Institute for Medical Research | Manhasset | New York |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | Aurora Health Care | Milwaukee | Wisconsin |
United States | Winthrop University Hospital | Mineola | New York |
United States | Minneapolis Heart Institute | Minneapolis | Minnesota |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | NCH Heart Institute | Naples | Florida |
United States | Columbia University Medical Center | New York | New York |
United States | New York University Langone Medical Center | New York | New York |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | The Miriam Hospital | Providence | Rhode Island |
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
United States | Sharp HealthCare | San Diego | California |
United States | Zuckerberg San Francisco General | San Francisco | California |
United States | Cardiology Associates of Schenectady | Schenectady | New York |
United States | Mayo Clinic in Arizona | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | Applied Health Research Centre, National Heart, Lung, and Blood Institute (NHLBI), Spartan Bioscience Inc. |
United States, Canada, Korea, Republic of, Mexico,
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, — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of the a Major Adverse Cardiovascular Event in Subjects Identified as CPY2C19 LOF Carriers by TaqMan. | 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. | 1 year after percutaneous coronary intervention (PCI) | |
Primary | Occurrence of the a Major Adverse Cardiovascular Event | Number of subjects to experience a major adverse cardiovascular event as defined as cardiovascular death, myocardial infarction, stroke, severe recurrent ischemia, and stent thrombosis. | Approximately 3 years after percutaneous coronary intervention (PCI) | |
Secondary | Thrombolysis in Myocardial Infarction Major or Minor Bleeding in Subjects Identified as CPY2C19 LOF Carriers by TaqMan. | Number of subjects that experienced thrombolysis in myocardial infarction major or minor bleeding in subjects identified as CYP2C19 LOF carriers by TaqMan | 1 year after percutaneous coronary intervention (PCI) | |
Secondary | Thrombolysis in Myocardial Infarction Major or Minor Bleeding | Number of subjects that experienced thrombolysis in myocardial infarction major or minor bleeding | Approximately 3 years after percutaneous coronary intervention (PCI) |
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