Tailored Antiplatelet Therapy Following PCI

• Register: ClinicalTrials.gov
• Last refreshed on: 17 August 2021
• Main ID: NCT01742117
• Date of registration: 03/12/2012
• Prospective Registration: Yes
• Primary sponsor: Mayo Clinic
• Public title: Tailored Antiplatelet Therapy Following PCI TAILOR-PCI
• Scientific title: Tailored Antiplatelet Initiation to Lesson Outcomes Due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention (TAILOR-PCI)
• Date of first enrolment: May 2013
• Target sample size: 5302
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01742117
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Canada, Korea, Republic of, Mexico, United States

Contacts

• Name: Michael E Farkouh, MD
• Affiliation: Toronto General Hospital

• Name: Kent R Bailey, PhD
• Affiliation: Mayo Clinic

• Name: Naveen Pereira, MD
• Affiliation: Mayo Clinic

Key inclusion & exclusion 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.)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Acute Coronary Syndrome

Coronary Artery Disease

Stenosis

Intervention(s)

Genetic: Retrospective Genotype testing

Other: Smartphone

Drug: Ticagrelor

Drug: Clopidogrel

Genetic: Prospective Genotype testing

Primary Outcome(s)

Occurrence of the a major adverse cardiovascular event (MACE) [Time Frame: Two years after percutaneous coronary intervention (PCI)]

Secondary Outcome(s)

Number of subjects with reduced function CYP2C19 allele(s) who have major or minor bleeding [Time Frame: Two years after percutaneous coronary intervention (PCI)]

Secondary ID(s)

11-006837

5U01HL128606

3U01HL128606-03S1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Applied Health Research Centre

National Heart, Lung, and Blood Institute (NHLBI)

Spartan Bioscience Inc.