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Tailored Antiplatelet Therapy Following PCI

Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Disease; Acute Coronary Syndrome; Stenosis

Intervention: Clopidogrel (Drug); Ticagrelor (Drug); Retrospective Genotype testing (Genetic); Prospective Genotype testing (Genetic)

Phase: Phase 4

Status: Recruiting

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
Naveen Pereira, MD, Principal Investigator, Affiliation: Mayo Clinic

Overall contact:
Kelly Paulson, Phone: 507-266-3415, Email: paulson.kelly@mayo.edu

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Occurrence of the a major adverse cardiovascular event (MACE)

Secondary outcome: Number of subjects with reduced function CYP2C19 allele(s) who have major or minor bleeding

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.)

Locations and Contacts

Kelly Paulson, Phone: 507-266-3415, Email: paulson.kelly@mayo.edu

Konyang University College of Medicine, Daejeon 302-718, Korea, Republic of; Recruiting
YoungHee Bae, Phone: 82-42-600-9409, Email: prettyyh0028@naver.com
Jang-Ho Bae, M.D., Principal Investigator

Chonnam National University Hospital, Gwangju 501-757, Korea, Republic of; Recruiting
Eun Jung Kim, Phone: 82.62.220.5783, Email: kej-shep@hanmail.net
Hyun Yee Gook, Phone: 82-62-220-5783, Email: kiznetic@hanmail.net
Myung Ho Jeong, M.D., Ph.D., Principal Investigator

Ajou University Hospital, Gyeonggi-do, Korea, Republic of; Recruiting
Jooyeon Yoon, Email: yoojoo82@naver.com
Hong-seok Lim, Principal Investigator

Chung-Ang University Hospital, Seoul 156-755, Korea, Republic of; Recruiting
Eun-mi Kim, Email: eunmi986.ek@gmail.com
Joonhwa Hong, M.D., Principal Investigator

Mayo Clinic in Arizona, Scottsdale, Arizona 85259, United States; Recruiting
Sheena Lamon, RN, Email: Lamon.Sheena@mayo.edu
John Sweeney, MD, Principal Investigator

Vancouver General Hospital, UBC Division of Cardiology, Vancouver, British Columbia V5N 3W9, Canada; Recruiting
Robyn Tkatch, Phone: 604-875-5106, Email: Robyn.Tkatch@vch.ca
Jennifer Timer, Phone: 604-875-5106, Email: Jennifer.Timer@vch.ca
Jacqueline Saw, MD, Principal Investigator

Mayo Clinic in Florida, Jacksonville, Florida 32224, United States; Recruiting
Grace Staggs, RN, Email: staggs.estela@mayo.edu
Gary E Lane, MD, Principal Investigator

NCH Heart Institute, Naples, Florida 34102, United States; Recruiting
Suzanne Kirkland, RN, Phone: 239-624-4242, Email: Suzanne.Kirkland@nchmd.org
Adam Frank, M.D., Principal Investigator

NorthShore University Health System, Evanston, Illinois 60201, United States; Recruiting
Ann Joseph, Phone: 847-570-3861, Email: AJoseph@northshore.org
Jorge Saucedo, M.D., Principal Investigator

St. Elizabeth Healthcare, Crestview Hills, Kentucky 41017, United States; Recruiting
Cindy Mulcahy, Phone: 859-301-4725, Email: Cynthia.mulcahy@stelizabeth.com
Mary Ann Burns, Phone: 859-301-4729, Email: Mary.Burns@stelizabeth.com
DP Suresh, MD, Principal Investigator

Essentia Institute of Rural Health, Duluth, Minnesota 55805, United States; Recruiting
Cathy Neva, Phone: 218-786-4867, Email: CNeva@Eirh.org
Jennifer Gunderson, Email: jgunderson2@eirh.org
Alok Bachuwar, MD, Principal Investigator

Minneapolis Heart Institute, Minneapolis, Minnesota 55407, United States; Recruiting
Amy McMeans, RN, Phone: 612-863-3895, Email: Amy.McMeans@allina.com
Ivan J Chavez, MD, Principal Investigator

University of Minnesota, Minneapolis, Minnesota 55455, United States; Recruiting
Emily Caldwell, Phone: 612-626-3656, Email: caldw076@umn.edu
Barbara Bruhn-Ding, Email: bruhn028@umn.edu
Ganesh Raveendran, MN, Principal Investigator

Mayo Clinic in Rochester, Rochester, Minnesota 55905, United States; Recruiting
Diane Batzel, Email: batzel.diane@mayo.edu
Jill Boyum, Email: boyum.jill@mayo.edu
Verghese Mathew, MD, Principal Investigator

The University of Mississippi Medical Center, Jackson, Mississippi 39216, United States; Not yet recruiting
Theresa Hickey, Phone: 601-984-5678, Email: tlhickey@umc.edu
Cameron S Guild, MD, Principal Investigator

Albany Medical College, Albany, New York 12208, United States; Recruiting
Wendy Stewart, Phone: 518-262-9316, Email: stewarw@mail.amc.edu
Mohammed El-Hajjar, MD, Principal Investigator
Mandeep Sidhu, MD, Sub-Investigator

The Feinstein Institute for Medical Research, Manhasset, New York 11030, United States; Recruiting
Miriam Lucca-Susana, Phone: 212-434-3734, Email: Mluccasusa@NSHS.edu
Kirk N Garratt, MSc, M.D., Principal Investigator

University of Ottawa Heart Institute, Ottawa, Ontario K1Y 4W7, Canada; Recruiting
Lyne Stuwe, RN, Email: LStuewe@ottawaheart.ca
Cheryl Charlebois, RN, Email: ccharlesbois@ottawaheart.ca
Derek So, MD, Principal Investigator

St Michael's Hospital, Toronto, Ontario M5B 1W8, Canada; Recruiting
Sandra Felix, RN, Email: felixS@smh.ca
John Graham, MD, Principal Investigator

Sunnybrook Health Services Center, Toronto, Ontario M4N 3M5, Canada; Recruiting
Patricia Reilly, Phone: 416-480-6060, Ext: 5253, Email: patricia.reilly@sunnybrook.ca
Mina Madan, MD, Principal Investigator

Toronto General Hospital - UHN, Toronto, Ontario M5B 2C4, Canada; Recruiting
Christina Drake, RN, Phone: 416 340 4800, Email: Christina.Drake@uhn.ca
Chris Overgaard, MD, Principal Investigator

Rhode Island Hospital, Providence, Rhode Island 02903, United States; Not yet recruiting
Lina Felix, Phone: 401-793-4105, Email: LFelix@Lifespan.org
Lori DeSimone, Phone: 401-793-5554, Email: LDesimone@Lifespan.org
Dawn Abbott, Principal Investigator

The Miriam Hospital, Providence, Rhode Island 02906, United States; Recruiting
Lina Felix, Phone: 401-793-4105, Email: LFelix@Lifespan.org
Lori DeSimone, Phone: 401-793-5554, Email: LDesimone@Lifespan.org
Paul Gordon, MD, Principal Investigator

MHS, Eau Claire, Eau Claire, Wisconsin 54702, United States; Recruiting
Vy T Nguyen, Phone: 715-464-8131, Email: Nguyen.Vy1@mayo.edu
Dawn Mrozonski, RN, Phone: 715-838-6356, Email: Mrozinski.Dawn@mayo.edu
Fearghas O'Cochlain, MD, Principal Investigator

Mayo Clinic Health System, LaCrosse, Wisconsin 54601, United States; Recruiting
Diane Johnson, RN, Email: Johnson.Diane5@mayo.edu
Charles R Cagin, DO, Principal Investigator

Additional Information

Starting date: May 2013
Last updated: February 11, 2015

Page last updated: August 23, 2015

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