Status:
ACTIVE_NOT_RECRUITING
Genotyping GUided Antiplatelet theRapy in pAtieNts Treated With Drug Eluting stEnts (GUARANTEE)
Lead Sponsor:
Beijing Anzhen Hospital
Conditions:
Angina, Stable
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ticagrelo...
Detailed Description
Background: P2Y12 receptor inhibitors are crucial for the management of patients undergoing coronary stenting. Although large-scale trials have shown that ticagrelor is superior to clopidogrel in term...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2026
Estimated Enrollment :
4009 Patients enrolled
Trial Details
Trial ID
NCT03783351
Start Date
May 27 2019
End Date
April 1 2026
Last Update
December 31 2025
Active Locations (9)
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1
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, China, 100000
2
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China, 100029
3
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100032
4
Fuwai Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100037