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

June 10, 2023 updated by: Mina Wageh Mohareb

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Faculty of medicine of girls, Cardiology department, Al-Azhar University in Cairo
        • Contact:
          • Nasima M Elkenany, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients with ACS undergoing PCI

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet Reactivity Index and maximum platelet aggregation
Time Frame: 24 hours after PCI
Platelet aggregation indicator
24 hours after PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mina Wageh Mohareb

Collaborators

Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

June 15, 2023

Study Completion (Estimated)

June 15, 2023

Study Registration Dates

First Submitted

June 10, 2023

First Submitted That Met QC Criteria

June 10, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 10, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Al-Azhar University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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