Combined Effect of Diabetes and cyp2c19 Polymorphism on Clopidogrel VS Ticagrelor Antiplatelet Activity in Patients of Anterior ST Elevation Myocardial Infarction Undergoing Primary PCI
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 1,022
- Locations
- 1
- Primary Endpoint
- Acute and sub-acute stent thrombosis
Study Overview
Brief Summary
In this study the combined effect of diabetes mellitus and cyp2c19 polymorphism on platelet aggregation inhibitory activity of the highest traditionally used loading dose 600 mg clopidogrel and ticagrelor 180 mg loading dose will be compared in acute coronary syndrome (ACS) patients undergoing PCI.
Detailed Description
Study subjects Inclusion criteria Diabetic patients (well-controlled type 2 diabetes mellitus) and non-diabetic patients with anterior ST-elevation and non-st elevation myocardial infarction undergoing PCI.
Exclusion criteria Patients who are with a family or personal history of bleeding. Patients with platelet count less than 100 x 103/ul. Patients with known hypersensitivity to clopidogrel or ticagrelor. Patients with serious bleeding tendency, history of intracranial hemorrhage, a sign of active bleeding, uncontrolled hypertension.
Patients with severe liver disorders
Methods The study will be conducted in the cardiac intensive care unit at Assiut educational hospital of cardiovascular diseases.
- diabetic and non-diabetic patients with ST-elevation and non-ST elevation myocardial infarction undergoing PCI will be enrolled in this study.
- At baseline, all patients will undergo full clinical examination and laboratory diagnostic tests. Current and previous medical history and medication history will be thoroughly investigated.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diabetic and non-diabetic patients with anterior ST-elevation and non-ST elevation myocardial infarction undergoing PCI.
Exclusion Criteria
- •Patients who are with a family or personal history of bleeding.
- •Patients with platelet count less than 100 x 103/ul.
- •Patients with known hypersensitivity to clopidogrel.
- •Patients with serious bleeding tendency, history of intracranial hemorrhage, signs of active bleeding, uncontrolled hypertension.
- •Patients with severe liver disorders
Arms & Interventions
Clopidogrel group
Anterior myocardial infarction patients undergoing percutaneous coronary intervention take loading dose 600 mg oral clopidogrel (plavix) tablets before the procedure.
Intervention: Clopidogrel (Drug)
Ticagrelor group
Anterior myocardial infarction patients undergoing percutaneous coronary intervention take loading dose180 mg oral ticagrelor (brilique) tablets before the procedure.
Intervention: Ticagrelor 90mg (Drug)
Outcomes
Primary Outcomes
Acute and sub-acute stent thrombosis
Time Frame: up to one month after stent implantation
stent thrombosis 24 hr to one month after stent implantation
Cardiovascular death
Time Frame: three to six months after PCI
Death with cardiovascular etiology
Ischemic or hemorrhagic stroke
Time Frame: three to six monthes after PCI
Non-fatal myocardial infarction
Time Frame: three to six months after PCI
Survival after hospital admission due to ST elevation or non-ST elevation myocardial infarction
Secondary Outcomes
No secondary outcomes reported
Investigators
Mina Wageh Mohareb
researcher at clinical pharmacology department cairo university, principal investigator
Cairo University