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

Sponsor
Mina Wageh Mohareb (Other)
Overall Status
Recruiting
CT.gov ID
NCT05911659
Collaborator
Al-Azhar University (Other)
60
Enrollment
1
Location
1.5
Anticipated Duration (Months)
40.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Ndividualized and Combined Effects of Diabetes and Smoking on the Antiplatelet Activity of Ticagrelor in Acute Myocardial Infarction Patients Undergoing Primary PCI
Actual Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Jun 15, 2023
Anticipated Study Completion Date :
Jun 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Non smokers- non diabetic patients

Drug: Ticagrelor
Patients with acute coronary syndromes undergo primary PCI and administered 180 mg loading dose ticagrelor before PCI
Other Names:
  • Primary percutaneous coronary intervention (PCI)

    		•
    smokers non diabetic patients

    Drug: Ticagrelor
    Patients with acute coronary syndromes undergo primary PCI and administered 180 mg loading dose ticagrelor before PCI
    Other Names:
  • Primary percutaneous coronary intervention (PCI)

    		•
    non smokers diabetic patients

    Drug: Ticagrelor
    Patients with acute coronary syndromes undergo primary PCI and administered 180 mg loading dose ticagrelor before PCI
    Other Names:
  • Primary percutaneous coronary intervention (PCI)

    		•
    smokers diabetic patients

    Drug: Ticagrelor
    Patients with acute coronary syndromes undergo primary PCI and administered 180 mg loading dose ticagrelor before PCI
    Other Names:
  • Primary percutaneous coronary intervention (PCI)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Platelet Reactivity Index and maximum platelet aggregation [24 hours after PCI]

      Platelet aggregation indicator

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of medicine of girls, Cardiology department, Al-Azhar University in Cairo Cairo Egypt

    Sponsors and Collaborators

    • Mina Wageh Mohareb
    • Al-Azhar University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mina Wageh Mohareb, Professor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05911659
    Other Study ID Numbers:
    • Al-Azhar University
    First Posted:
    Jun 22, 2023
    Last Update Posted:
    Jun 22, 2023
    Last Verified:
    Jun 1, 2023
    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
    Diabetes Mellitus
    Infarction
    Ticagrelor

    Study Results

    No Results Posted as of Jun 22, 2023