An observational study in Myocardial Infarction, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-01-14.
Sponsored by Cairo University · Observational
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.
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.
Recruited patients will be classified into two groups. One group will receive 600 mg loading dose clopidogrel before PCI and 75 mg daily maintenance dose. The other group of patients will receive 180 mg loading dose ticagrelor before PCI and 90 mg twice daily maintenance dose.
A blood sample of will be withdrawn from each patient to undergo genotypic testing using Real Time polymerase chain reaction (PCR) to detect polymorphism in the cyp2c19 enzyme.
Study endpoints Acute stent thrombosis 24 hours after PCI and sub-acute stent thrombosis within 30 days after PCI, cardiovascular death, recurrent acute cardiac events, recurrent unstable anginal pain and hospitalization for cardiovascular diseases.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 1,022 is above the median of 500 across 983 observational studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Diabetic and non-diabetic patients with ST-elevation elevation and non-ST elevation myocardial infarction undergoing PCI.
-Diabetic and non-diabetic patients with anterior ST-elevation and non-ST elevation myocardial infarction undergoing PCI.
Exclusion Criteria:
Anterior myocardial infarction patients undergoing percutaneous coronary intervention take loading dose 600 mg oral clopidogrel (plavix) tablets before the procedure.
Drug: Clopidogrel
Anterior myocardial infarction patients undergoing percutaneous coronary intervention take loading dose180 mg oral ticagrelor (brilique) tablets before the procedure.
Drug: Ticagrelor 90mg
8 tablets 75 mg clopidogrel loading dose before PCI
Also known as: plavix
2 tablets 90 mg brilique before PCI
Also known as: brilique
Acute and sub-acute stent thrombosis
stent thrombosis 24 hr to one month after stent implantation
Time frame: up to one month after stent implantation
Cardiovascular death
Death with cardiovascular etiology
Time frame: three to six months after PCI
Non-fatal myocardial infarction
Survival after hospital admission due to ST elevation or non-ST elevation myocardial infarction
Time frame: three to six months after PCI
Ischemic or hemorrhagic stroke
Time frame: three to six monthes after PCI
Plan to share: No
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Cairo University