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

NCT ID: NCT02026219

Last Updated: 2015-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Clopidogrel

Clopidogrel 600mg loading

Group Type EXPERIMENTAL

Clopidogrel

Intervention Type DRUG

Clopidogrel 600mg loading

Ticagrelor

Ticagrelor 180mg loading

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

Ticagrelor 180mg loading

Interventions

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Clopidogrel

Clopidogrel 600mg loading

Intervention Type DRUG

Ticagrelor

Ticagrelor 180mg loading

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inha University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Inha University Hospital

Incheon, Incheon, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 24885437 (View on PubMed)

Other Identifiers

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IUH-IRB-13-2256

Identifier Type: -

Identifier Source: org_study_id

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