Ignite Creation Date:
2024-05-06 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03613857
Status:
COMPLETED
Last Update Posted:
2019-01-14
First Post:
2018-07-29
Brief Title:
Effect of Diabetes and Hepatic Enzymes Mutation on Clopidogrel VS Ticagrelor Activity in Myocardial Infarction MI Patients Undergoing Primary Percutaneous Coronary Intervention PCI
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Combined Effect of Diabetes and cyp2c19 Polymorphism on Clopidogrel VS Ticagrelor Antiplatelet Activity in Patients of Anterior ST Elevation Myocardial Infarction Undergoing Primary PCI
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 103ul 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
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
Clopidogrel and ticagrelor antiplatelet activity will be assessed by estimating the maximum platelet aggregation MPA using light transmittance platelet aggregometry and platelet reactivity index PRI using whole-blood vasodilator-stimulated phosphoprotein VASP measured by quantitative flow cytometry
All patients will be followed-up for at least three to six months month by clinic visits and phone calls to detect acute and subacute stent thrombosis acute cardiac events revascularization and cardiovascular death after PCI
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
Exclusion criteria Patients who are with a family or personal history of bleeding Patients with platelet count less than 100 x 103ul 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
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
Clopidogrel and ticagrelor antiplatelet activity will be assessed by estimating the maximum platelet aggregation MPA using light transmittance platelet aggregometry and platelet reactivity index PRI using whole-blood vasodilator-stimulated phosphoprotein VASP measured by quantitative flow cytometry
All patients will be followed-up for at least three to six months month by clinic visits and phone calls to detect acute and subacute stent thrombosis acute cardiac events revascularization and cardiovascular death after PCI
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None