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Coronary Artery DiseasePhase 4TAILOR-PCINCT01742117

Tailored Antiplatelet Therapy Following PCI

A Phase 4 study testing Clopidogrel and Ticagrelor in people with Coronary Artery Disease and Acute Coronary Syndrome, run by Mayo Clinic at 41 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Clopidogrel and Ticagrelor
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,276 participants
Where
41 sitesin 4 countries
Study dates
May 2013to 31 Oct 2020
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 30Show fewer
  • 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.)

Who cannot join

None listed.

Trial locations and contacts

41 sites in 4 countries.

41 sites in 4 countries

United States26 sites

  • Albany Medical College

    Albany, New York, 12208

  • St. Elizabeth Healthcare

    Crestview Hills, Kentucky, 41017

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Essentia Institute of Rural Health

    Duluth, Minnesota, 55805

  • MHS, Eau Claire

    Eau Claire, Wisconsin, 54702

  • NorthShore University Health System

    Evanston, Illinois, 60201

  • Greenville Health System

    Greenville, South Carolina, 29605

  • The University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224

  • Mayo Clinic Health System

    La Crosse, Wisconsin, 54601

  • The Feinstein Institute for Medical Research

    Manhasset, New York, 11030

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Aurora Health Care

    Milwaukee, Wisconsin, 53215

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • NCH Heart Institute

    Naples, Florida, 34102

  • New York University Langone Medical Center

    New York, New York, 10016

  • Columbia University Medical Center

    New York, New York, 10032

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Sharp HealthCare

    San Diego, California, 92123

  • Zuckerberg San Francisco General

    San Francisco, California, 94110

  • Cardiology Associates of Schenectady

    Schenectady, New York, 12309

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

Other trials in United States

Canada8 sites

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

  • Regina General Hospital

    Regina, Saskatchawan, S4P 0W5

  • Thunder Bay Regional Health Sciences Centre

    Thunder Bay, Ontario, P7B 6V4

  • Humber River Hospital

    Toronto, Ontario, M3M 0B2

  • Sunnybrook Health Services Center

    Toronto, Ontario, M4N 3M5

  • St Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • Toronto General Hospital - UHN

    Toronto, Ontario, M5B 2C4

  • Vancouver General Hospital, UBC Division of Cardiology

    Vancouver, British Columbia, V5N 3W9

Other trials in Canada

South Korea4 sites

  • Konyang University College of Medicine

    Daejeon, 302-718

  • Chonnam National University Hospital

    Gwangju, 501-757

  • Ajou University Hospital

    Gyeonggi-do

  • Chung-Ang University Hospital

    Seoul, 156-755

Other trials in South Korea

Mexico3 sites

  • Hospital de Especialidades, Centro Medico Nacional 'La Raza'

    Mexico City, 02990

  • Hospital REgional No. 1

    Mexico City, 03100

  • Hospital de Cardiologia, Centro Medico Nacional Siglo XXI

    Mexico City, 06720

Other trials in Mexico

About this study

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

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.

Read the 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.

Being tested
Clopidogrel, Ticagrelor
Keywords
percutaneous coronary intervention, angioplasty
Medical subject headings
Coronary Artery Disease, Acute Coronary Syndrome, Constriction, Pathologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ClopidogrelDrug

    Also called Plavix

    One 75 mg tablet per day by mouth for one year

  • TicagrelorDrug

    Also called Brilinta

    One 90 mg tablet twice per day by mouth for one year

Study groups in NCT01742117
Study groupRoleWhat they receive
Genotype-Guided TherapyExperimentalSubjects 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.
Receives: Drug: Clopidogrel; Drug: Ticagrelor
Conventional TherapyActive comparatorSubjects 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.
Receives: Drug: Clopidogrel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year after percutaneous coronary intervention (PCI)

  2. 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.

    Measured: Approximately 3 years after percutaneous coronary intervention (PCI)

Secondary outcomes (2)

  1. 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

    Measured: 1 year after percutaneous coronary intervention (PCI)

  2. Thrombolysis in Myocardial Infarction Major or Minor Bleeding

    Number of subjects that experienced thrombolysis in myocardial infarction major or minor bleeding

    Measured: Approximately 3 years after percutaneous coronary intervention (PCI)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2012 (estimated)
  2. Study startMay 2013
  3. Primary completion31 Oct 2020
  4. Study completion31 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5,276 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01742117
Sponsor's protocol ID
11-006837
Other IDs
5U01HL128606, 3U01HL128606-03S1
Acronym
TAILOR-PCI
Status last verified
Oct 2021
First submitted
3 Dec 2012
Last updated
9 Nov 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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, Bailey K, Rihal C. Effect of Genotype-Guided Oral P2Y12 Inhibitor Selection vs Conventional Clopidogrel Therapy on Ischemic Outcomes After Percutaneous Coronary Intervention: The TAILOR-PCI Randomized Clinical Trial. JAMA. 2020 Aug 25;324(8):761-771. doi: 10.1001/jama.2020.12443.

    PubMed 32840598

  • Grant CW, Ingraham BS, Lennon RJ, Raina A, Tian S, Kowlgi G, Cavallari LH, Lee CR, Beitelshees A, Angiolillo DJ, Franchi F, Duarte JD, Rossi JS, Stouffer GA, Klee E, Gulati R, Rihal C, Farkouh M, Athreya AP, Pereira NL. Machine Learning With Genetic and Clinical Data to Predict Ischemic Outcomes After PCI. Clin Transl Sci. 2026 Jul;19(7):e70655. doi: 10.1111/cts.70655.

    PubMed 42427167

  • Ingraham BS, Farkouh ME, Lennon RJ, So D, Goodman SG, Geller N, Bae JH, Jeong MH, Baudhuin LM, Mathew V, Bell MR, Lerman A, Fu YP, Hasan A, Iturriaga E, Tanguay JF, Welsh RC, Rosenberg Y, Bailey K, Rihal C, Pereira NL. Genetic-Guided Oral P2Y12 Inhibitor Selection and Cumulative Ischemic Events After Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2023 Apr 10;16(7):816-825. doi: 10.1016/j.jcin.2023.01.356.

    PubMed 37045502

  • Mathew RO, Sidhu MS, Rihal CS, Lennon R, El-Hajjar M, Yager N, Lyubarova R, Abdul-Nour K, Weitz S, O'Cochlain DF, Murthy V, Levisay J, Marzo K, Graham J, Dzavik V, So D, Goodman S, Rosenberg YD, Pereira N, Farkouh ME. Safety and Efficacy of CYP2C19 Genotype-Guided Escalation of P2Y12 Inhibitor Therapy After Percutaneous Coronary Intervention in Chronic Kidney Disease: a Post Hoc Analysis of the TAILOR-PCI Study. Cardiovasc Drugs Ther. 2024 Jun;38(3):447-457. doi: 10.1007/s10557-022-07392-2. Epub 2022 Nov 29.

    PubMed 36445624

  • Avram R, So D, Iturriaga E, Byrne J, Lennon R, Murthy V, Geller N, Goodman S, Rihal C, Rosenberg Y, Bailey K, Farkouh M, Bell M, Cagin C, Chavez I, El-Hajjar M, Ginete W, Lerman A, Levisay J, Marzo K, Nazif T, Olgin J, Pereira N. Patient Onboarding and Engagement to Build a Digital Study After Enrollment in a Clinical Trial (TAILOR-PCI Digital Study): Intervention Study. JMIR Form Res. 2022 Jun 13;6(6):e34080. doi: 10.2196/34080.

    PubMed 35699977

  • Madan M, Abbott JD, Lennon R, So DYF, MacDougall AM, McLaughlin MA, Murthy V, Saw J, Rihal C, Farkouh ME, Pereira NL, Goodman SG; TAILOR-PCI Investigators *. Sex-Specific Differences in Clinical Outcomes After Percutaneous Coronary Intervention: Insights from the TAILOR-PCI Trial. J Am Heart Assoc. 2022 Jun 21;11(12):e024709. doi: 10.1161/JAHA.121.024709. Epub 2022 Jun 14.

    PubMed 35699175

  • Baudhuin LM, Train LJ, Goodman SG, Lane GE, Lennon RJ, Mathew V, Murthy V, Nazif TM, So DYF, Sweeney JP, Wu AHB, Rihal CS, Farkouh ME, Pereira NL. Point of care CYP2C19 genotyping after percutaneous coronary intervention. Pharmacogenomics J. 2022 Dec;22(5-6):303-307. doi: 10.1038/s41397-022-00278-4. Epub 2022 Apr 21.

    PubMed 35449399

  • Capodanno D, Angiolillo DJ, Lennon RJ, Goodman SG, Kim SW, O'Cochlain F, So DY, Sweeney J, Rihal CS, Farkouh M, Pereira NL. ABCD-GENE Score and Clinical Outcomes Following Percutaneous Coronary Intervention: Insights from the TAILOR-PCI Trial. J Am Heart Assoc. 2022 Feb 15;11(4):e024156. doi: 10.1161/JAHA.121.024156. Epub 2022 Feb 8.

    PubMed 35132875

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Clopidogrel and Ticagrelor in people with Coronary Artery Disease and Acute Coronary Syndrome, run by Mayo Clinic at 41 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, Canada, South Korea, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of the a Major Adverse Cardiovascular Event in Subjects Identified as CPY2C19 LOF Carriers by TaqMan. (time frame: 1 year after percutaneous coronary intervention (PCI)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01742117, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.

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