Comparison of Clopidogrel and Ticagrelor on Microvascular Dysfunction in ST-Segment Elevation Myocardial Infarction

September 30, 2015 updated by: Inha University Hospital

Comparison of Clopidogrel and Ticagrelor on Microvascular Dysfunction in Acute Coronary Syndrome Patients: The Index of MIcrocirculatory Resistance After PCI in STEMI Patients (TIME Study)

Ticagrelor is a non-thienophyridine, direct P2Y12 blocker that is more potent than clopidogrel and is associated with less interindividual variability. In the PLATO trial, it was found to be superior to clopidogrel with respect to cardiovascular outcomes and total mortality without increasing the risk of bleedings.

More potent and reversible receptor bindings are possible explanation for the superior outcomes. Beside the potent effect on inhibition of antiplatelet function, ticagrelor has previously been demonstrated to increase adenosine levels by inhibiting adenosine re-uptake in tissue level and can induce adenosine triphosphate (ATP) release from human red cells, which both stimulate vasodilation of in red blood cells.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • Inclusion Criteria:

    • Males and Females
    • between the ages of 18 and 75 years
    • STEMI patients treated with percutaneous coronary intervention
    • Able to provide informed consent

  • Exclusion Criteria:

    • History of stroke or transient ischemic attack
    • Platelet count < 100 000/μL
    • Known Bleeding Diathesis
    • Hematocrit <30% or >52%
    • Severe Liver Dysfunction
    • Renal Insufficiency (Creatinine Clearance < 30ml/min)
    • Pregnant females
    • Cardiogenic shock or symptomatic hypotension or sitting SBP < 95 mmHg

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clopidogrel
Clopidogrel 600mg loading
Drug: Clopidogrel
Clopidogrel 600mg loading
Experimental: Ticagrelor
Ticagrelor 180mg loading
Drug: Ticagrelor
Ticagrelor 180mg loading

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Index of microcirculatory resistance (IMR) measured after successful coronary intervention
Time Frame: IMR will be immediately assessed after successful PCI patients within 48hr from admission
IMR will be immediately assessed after successful PCI patients within 48hr from admission

Secondary Outcome Measures

Outcome Measure
Time Frame
wall motion score index on three month later TTE from index PCI
Time Frame: TTE will be assessed in all enrolled patients 3 month later from index PCI
TTE will be assessed in all enrolled patients 3 month later from index PCI

Collaborators and Investigators

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

Sponsor

Inha University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

December 24, 2013

First Submitted That Met QC Criteria

December 30, 2013

First Posted (Estimate)

January 1, 2014

Study Record Updates

Last Update Posted (Estimate)

October 1, 2015

Last Update Submitted That Met QC Criteria

September 30, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUH-IRB-13-2256

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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