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 (Other)
• Overall Status: Completed
• CT.gov ID: NCT03613857
• Collaborator: (none)
• Enrollment: 1,022
• Location: 1
• Actual Duration (Months): 15.4
• Patients Per Site Per Month: 66.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction	Drug: Clopidogrel; Drug: Ticagrelor 90mg

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.

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A blood sample of will be withdrawn from each patient to undergo genotypic testing using Real Time polymerase chain reaction (PCR) to detect polymorphism in the cyp2c19 enzyme.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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 1022 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Apr 15, 2017
• Actual Primary Completion Date: Jul 28, 2018
• Actual Study Completion Date: Jul 28, 2018

Arms and Interventions

Arm	Intervention/Treatment
Clopidogrel group Anterior myocardial infarction patients undergoing percutaneous coronary intervention take loading dose 600 mg oral clopidogrel (plavix) tablets before the procedure.	Drug: Clopidogrel; 8 tablets 75 mg clopidogrel loading dose before PCI; Other Names: plavix
Ticagrelor group Anterior myocardial infarction patients undergoing percutaneous coronary intervention take loading dose180 mg oral ticagrelor (brilique) tablets before the procedure.	Drug: Ticagrelor 90mg; 2 tablets 90 mg brilique before PCI; Other Names: brilique

Outcome Measures

Primary Outcome Measures

1. Acute and sub-acute stent thrombosis [up to one month after stent implantation]

   stent thrombosis 24 hr to one month after stent implantation

2. Cardiovascular death [three to six months after PCI]

   Death with cardiovascular etiology

3. Non-fatal myocardial infarction [three to six months after PCI]

   Survival after hospital admission due to ST elevation or non-ST elevation myocardial infarction

4. Ischemic or hemorrhagic stroke [three to six monthes after PCI]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of pharmacy Cairo university	Cairo		Egypt	01234567

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mina Wageh Mohareb, researcher at clinical pharmacology department cairo university, principal investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT03613857
• Other Study ID Numbers: pharmacology department CU
• First Posted: Aug 3, 2018
• Last Update Posted: Jan 14, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Myocardial Infarction; Infarction; Clopidogrel; Ticagrelor

Study Results

No Results Posted as of Jan 14, 2019