Study S002612

Randomized Controlled Trial for Evaluating CYP2C19 Allele Genotype-guided Clopidogrel Treatment Outcomes in Real-world Practice After the ePCI

ClinicalTrials.gov record Study Protocol and Statistical Analysis Plan (PDF)Informed Consent Form (PDF)

Registration

Registration: NCT06665919
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Masking: TRIPLE
Status: COMPLETED
Enrollment: 283
Start: 2023-06-15
Primary completion: 2025-05-15
Lead sponsor: Vistamedi Ltd.
Conditions: Coronary Artery Disease; Clopidogrel Resistance; Coronary Thrombosis; Adverse Cardiac Events; Bleeding; Hospitalisations; Death; Death From Cardiovascular Disease
Interventions: OTHER:CYP2C19 Genotype-Guided Clopidogrel Treatment; OTHER:CYP2C19 Genotype Guided Antiplatelet Treatment Alternative to Clopidogrel; OTHER:The Conventional Clopidogrel Treatment
Results posted: TRUE
Individual participant data sharing: YES

Registered primary outcomes

Number of Study Participants Who Died From Any Cause (Death From Any Cause) [within a 12-month of the study follow-up]
Number of Study Participants Who Died From Any Cardiovascular Cause (Death From Cardiovascular Cause) [within a 12-month of the study follow-up]
Number of Study Participants Who Died From Non-cardiovascular Causes (Death From Non-cardiovascular Cause) [within a 12-month of the study follow-up]

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