Genotyping GUided Antiplatelet theRapy in pAtieNts Treated With Drug Eluting stEnts (GUARANTEE) (NCT03783351) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Genotyping GUided Antiplatelet theRapy in pAtieNts Treated With Drug Eluting stEnts (GUARANTEE)
China4,009 participantsStarted 2019-05-27
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 insuffic…
What they're measuring
1
Occurrence of main adverse cardiovascular and cerebrovascular events (MACCE)