Acute Coronary Syndrome Clinical Trial
Official title:
CYP2C19 Genotype-GUided Dual Antiplatelet theRapy in pAtieNts Treated With New Generation Drug Eluting stEnts (the GUARANTEE Study)
NCT number | NCT03783351 |
Other study ID # | GUARANTEE |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 27, 2019 |
Est. completion date | February 2025 |
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.
Status | Recruiting |
Enrollment | 4009 |
Est. completion date | February 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Beijing Anzhen Hospital | Beijing | Beijing |
China | Beijing Chaoyang Hospital | Beijing | Beijing |
China | Beijing Friendship Hospital | Beijing | Beijing |
China | Beijing LuHe Hospital | Beijing | Beijing |
China | Beijing Tian Tan Hospital | Beijing | Beijing |
China | Beijing Tong Ren Hospital | Beijing | Beijing |
China | Beijing Tsinghua Changgung Hospital | Beijing | Beijing |
China | China-Japan Friendship Hospital | Beijing | Beijing |
China | Fuwai Hospital Chinese Academy of Medical Sciences | Beijing | Beijing |
China | Peking Union Medical College Hospital | Beijing | Beijing |
China | West China Hospital Sichuan University | Chengdu | Sichuan |
China | The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Beijing Anzhen Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of main adverse cardiovascular and cerebrovascular events (MACCE) | MACCE will include all-cause death, non-fatal stroke, non-fatal myocardial infarction (MI) and ischemia driven revascularization at one-year follow-up. | 1 year |
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