Individualized and Combined Effects of Diabetes and Smoking on the Antiplatelet Activity of Ticagrelor in Acute Myocardial Infarction Patients Undergoing Primary PCI

NCT ID: NCT05911659

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2023-06-15

Brief Summary

Background:Diabetes and smoking are common factors found to increase platelet reactivity in patients undergoing primary PCI. Objective: Compare the individualized and combined effects of smoking and diabetes on the antiplatelet activity in patients undergoing primary PCI. Methods: sixty patients were recruited in this study. Patients were allocated to one of four groups according to the diabetes and smoking status. Non smokers- non diabetic patients, smokers non diabetic patients, non smokers diabetic patients, and smokers diabetic patients, 15 patients in each group. All patients received 180 mg ticagrelor before PCI. Platelet reactivity index(PRI) and maximum platelet aggregation were measured 24 hours after ticagrelor loading dose for each patient as indicators for antiplatelet efficacy. PRI and/or MPA values > 50% were defined as high platelet reactivity.

Conditions

Individualized and Combined Effects of Smoking and Diabetes on the Antiplatelet Activity in Patients Undergoing Primary Percutaneous Coronary Intervention

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Non smokers- non diabetic patients

Ticagrelor

Intervention Type: DRUG

Patients with acute coronary syndromes undergo primary PCI and administered 180 mg loading dose ticagrelor before PCI

smokers non diabetic patients

Ticagrelor

Intervention Type: DRUG

Patients with acute coronary syndromes undergo primary PCI and administered 180 mg loading dose ticagrelor before PCI

non smokers diabetic patients

Ticagrelor

Intervention Type: DRUG

Patients with acute coronary syndromes undergo primary PCI and administered 180 mg loading dose ticagrelor before PCI

smokers diabetic patients

Ticagrelor

Intervention Type: DRUG

Patients with acute coronary syndromes undergo primary PCI and administered 180 mg loading dose ticagrelor before PCI

Interventions

Ticagrelor

Patients with acute coronary syndromes undergo primary PCI and administered 180 mg loading dose ticagrelor before PCI

Intervention Type: DRUG

Other Intervention Names

Primary percutaneous coronary intervention (PCI)

Eligibility Criteria

Inclusion Criteria

Acute coronary syndrome (ACS) undergoing PCI

Exclusion Criteria

Patients who had a history of severe bleeding, serious bleeding tendency, history of intracranial hemorrhage, signs of active bleeding, thrombocytopenia, uncontrolled hypertension, hypersensitivity to the used drugs (clopidogrel or ticagrelor), concomitant use of strong CYP inducers or inhibitors, and/or severe liver disorders were excluded from the study.

Patients with previous history of coronary artery disease, previous PCI or patients administering other antiplatelets were excluded from the current study.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: collaborator

Mina Wageh Mohareb

OTHER

Sponsor Role: lead

Responsible Party

Mina Wageh Mohareb

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Faculty of medicine of girls, Cardiology department, Al-Azhar University in Cairo

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Nasima M El-Kenany, Ph.D

Role: CONTACT

mina.moharebmedicinewolters@gmail.com

01007844927 ext. +20

Facility Contacts

Nasima M Elkenany, Ph.D.

Role: primary

Other Identifiers

Al-Azhar University

Identifier Type: -

Identifier Source: org_study_id