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

Primary Purpose

Non-ST Segment Elevation Myocardial Infarction, ST Segment Elevation Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Clopidogrel
Ticagrelor
Sponsored by
Inha University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-ST Segment Elevation Myocardial Infarction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

  • 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

Sites / Locations

  • Inha University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Clopidogrel

Ticagrelor

Arm Description

Clopidogrel 600mg loading

Ticagrelor 180mg loading

Outcomes

Primary Outcome Measures

Index of microcirculatory resistance (IMR) measured after successful coronary intervention

Secondary Outcome Measures

wall motion score index on three month later TTE from index PCI

Full Information

First Posted
December 24, 2013
Last Updated
September 30, 2015
Sponsor
Inha University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02026219
Brief Title
Comparison of Clopidogrel and Ticagrelor on Microvascular Dysfunction in ST-Segment Elevation Myocardial Infarction
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inha University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-ST Segment Elevation Myocardial Infarction, ST Segment Elevation Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clopidogrel
Arm Type
Experimental
Arm Description
Clopidogrel 600mg loading
Arm Title
Ticagrelor
Arm Type
Experimental
Arm Description
Ticagrelor 180mg loading
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
Clopidogrel 600mg loading
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Intervention Description
Ticagrelor 180mg loading
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
24885437
Citation
Park SD, Baek YS, Woo SI, Kim SH, Shin SH, Kim DH, Kwan J, Park KS. Comparing the effect of clopidogrel versus ticagrelor on coronary microvascular dysfunction in acute coronary syndrome patients (TIME trial): study protocol for a randomized controlled trial. Trials. 2014 May 1;15:151. doi: 10.1186/1745-6215-15-151.
Results Reference
derived

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

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