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Active, not recruiting Not applicable

Genotyping GUided Antiplatelet theRapy in pAtieNts Treated With Drug Eluting stEnts (GUARANTEE)

NCT03783351 · tracked via the Priya Life Science Japan tracker
Phase
Not applicable
Started
2019-05-27
Last updated
2025-12-31

Condition(s) studied

Angina, StableAcute Coronary SyndromeDrug-Eluting StentsGenotype

Investigational drug(s) / intervention(s)

CYP2C19 genotype testing

CYP2C19 genotype testing: CYP2C19 genotype testing will be conducted in a designated central laboratory.

Study summary

The aim of this study is to assess the efficacy and safety of the CYP2C19 genotype guided antiplatelet treatment strategy, using clopidogrel in non-carriers of a CYP2C19\*2 or \*3 allele and ticagrelor in carriers of a CYP2C19\*2 or \*3 allele in patients treated with new generation drug eluting stents.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient ≥18 years of age * Patient presents with acute coronary syndrome (ACS) or stable coronary artery disease (SCAD) * Patient has a percutaneous coronary intervention (PCI) indication and the new generation drug eluting stent(s) is successfully implanted Exclusion Criteria: * Patient unable to receive 12 months of dual anti-platelet therapy * Patient developing procedure-related complications such as stent thrombosis, coronary dissection, coronary perforation, cardiac tamponade or no-reflow during PCI * Contraindicated or allergic to clopidogrel or ticagrelor * Patient or physician refusal to enroll in the study * Patient having received thrombolytic therapy within the previous 24 hours * Physician has known the patient's CYP2C19 genotype * Anticipated discontinuation of dual anti-platelet therapy within the 12-month follow-up period, example for elective surgery * History of intracranial hemorrhage * Patient has a history of bleeding diathesis or coagulopathy * Patient has an active pathological bleeding, such as active gastrointestinal (GI) bleeding * Patient is pregnant, breastfeeding, or planning to become pregnant within 12 months * Patient is receiving chronic oral anticoagulation therapy (i.e., vitamin K antagonist, direct thrombin inhibitor, Factor Xa inhibitor) * Patient with cardiogenic shock or mechanical circulatory assist devices placed * Patient with LVEF \<30% * Patient with active liver diseases * Patient with severe renal insufficiency (eGFR \<30ml/min/1.73m2 based on simplified MDRD equation or CrCl \<30ml/min based on Cockcroft-Gault equation) * Patient has a malignancy or a life expectancy of less than one year * Platelet count \<100 000/μL, or hematocrit \<32% or \>52%, or white blood cell count \<3000/μL

Primary outcome measure(s)

  • Occurrence of main adverse cardiovascular and cerebrovascular events (MACCE) — 1 year
    MACCE will include all-cause death, non-fatal stroke, non-fatal myocardial infarction (MI) and ischemia driven revascularization at one-year follow-up.

Trial sites (9)

FacilityCityRegionStatus
Beijing Chaoyang Hospital Beijing Beijing Municipality
Beijing Anzhen Hospital Beijing Beijing Municipality
Peking Union Medical College Hospital Beijing Beijing Municipality
Fuwai Hospital Chinese Academy of Medical Sciences Beijing Beijing Municipality
Beijing Friendship Hospital Beijing Beijing Municipality
Beijing Tong Ren Hospital Beijing Beijing Municipality
Beijing LuHe Hospital Beijing Beijing Municipality
Beijing Tsinghua Changgung Hospital Beijing Beijing Municipality
China-Japan Friendship Hospital Beijing Beijing Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03783351 on ClinicalTrials.gov ↗ ← All trials in Japan