Tailored Antiplatelet Initiation to Lesson Outcomes Due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention (TAILOR-PCI)

Who is this study for? Adults with acute coronary syndrome or stable coronary artery disease
What treatments are being studied? Clopidogrel
Status: Completed
Location: See all (41) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

⁃ 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

• 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.)

Locations
United States
Arizona
Mayo Clinic in Arizona
Scottsdale
California
Sharp HealthCare
San Diego
Zuckerberg San Francisco General
San Francisco
Florida
Mayo Clinic in Florida
Jacksonville
NCH Heart Institute
Naples
Illinois
NorthShore University Health System
Evanston
Loyola University Medical Center
Maywood
Kentucky
St. Elizabeth Healthcare
Crestview Hills
Michigan
Henry Ford Hospital
Detroit
Minnesota
Essentia Institute of Rural Health
Duluth
Minneapolis Heart Institute
Minneapolis
University of Minnesota
Minneapolis
Mayo Clinic in Rochester
Rochester
Mississippi
The University of Mississippi Medical Center
Jackson
New York
Albany Medical College
Albany
The Feinstein Institute for Medical Research
Manhasset
Winthrop University Hospital
Mineola
Columbia University Medical Center
New York
New York University Langone Medical Center
New York
Cardiology Associates of Schenectady
Schenectady
Rhode Island
Rhode Island Hospital
Providence
The Miriam Hospital
Providence
South Carolina
Greenville Health System
Greenville
Wisconsin
MHS, Eau Claire
Eau Claire
Mayo Clinic Health System
La Crosse
Aurora Health Care
Milwaukee
Other Locations
Canada
University of Ottawa Heart Institute
Ottawa
Regina General Hospital
Regina
Thunder Bay Regional Health Sciences Centre
Thunder Bay
Humber River Hospital
Toronto
St Michael's Hospital
Toronto
Sunnybrook Health Services Center
Toronto
Toronto General Hospital - UHN
Toronto
Vancouver General Hospital, UBC Division of Cardiology
Vancouver
Mexico
Hospital de Cardiologia, Centro Medico Nacional Siglo XXI
Mexico City
Hospital de Especialidades, Centro Medico Nacional 'La Raza'
Mexico City
Hospital REgional No. 1
Mexico City
Republic of Korea
Konyang University College of Medicine
Daejeon
Chonnam National University Hospital
Gwangju
Ajou University Hospital
Gyeonggi-do
Chung-Ang University Hospital
Seoul
Time Frame
Start Date: May 2013
Completion Date: October 31, 2020
Participants
Target number of participants: 5276
Treatments
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.
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.
Authors
Charles R Cagin, Kevin Marzo, Ronald Goldberg, Adam Frank, Malcolm Bell, Alan Wu, Tamim Nazif, Jorge Saucedo, Wilson Ginete, Ivan J Chavez, Ganesh Raveendran, Paul Gordon, Josh R Doll, Mandeep Sidhu, Cameron S Guild, Amir Darki, John Sweeney, Michael E Farkouh, Verghese Mathew, Louai Razzouk, Naveen Pereira, Gary E Lane, Steven Weitz, Chris Overgaard, Irving Tiong, Myung Ho Jeong, John Graham, Fearghas O'Cochlain, Joonhwa Hong, Kent R Bailey, Hong-seok Lim, Mina Madan, DP Suresh, Mohammed El-Hajjar, Jacqueline Saw, Andrea MacDougall, Derek So, Jang-Ho Bae, Dawn Abbott, Khaled Nour
Sponsors
Leads: Mayo Clinic
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Spartan Bioscience Inc., Applied Health Research Centre

This content was sourced from clinicaltrials.gov

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