Tailored Antiplatelet Therapy Following PCI

Overview

  • Study type

    Interventional
  • Study phase

    IV
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Jacksonville, Florida: 11-006837
    • Rochester, Minnesota: 11-006837
    • Eau Claire, Wisconsin: 11-006837
    • Scottsdale/Phoenix, Arizona: 11-006837
    • La Crosse, Wisconsin: 11-006837
    NCT ID: NCT01742117
    Sponsor Protocol Number: 11-006837

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.)

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Gary Lane, M.D.

Open for enrollment

Contact information:

Geraldine Simpson R.N., CCRP

Rochester, Minn.

Mayo Clinic principal investigator

Malcolm Bell, M.D.

Open for enrollment

Contact information:

Naveen Pereira M.D.

(507)284-7136

Pereira.Naveen@mayo.edu

Eau Claire, Wis.

Mayo Clinic principal investigator

Deaglan O'Cochlain, M.D.

Open for enrollment

Contact information:

Vy Nguyen

(480)342-6428

Nguyen.Vy1@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

John Sweeney, M.D.

Open for enrollment

Contact information:

Sheena Lamon R.N.

(480)342-0168

Lamon.Sheena@mayo.edu

La Crosse, Wis.

Mayo Clinic principal investigator

Charles Cagin, D.O.

Open for enrollment

Contact information:

Carolyn Flock

(608)392-9462

Flock.Carolyn@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20147582

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