Comparison of Clopidogrel and Ticagrelor on Microvascular Dysfunction in ST-Segment Elevation Myocardial Infarction
1 other identifier
interventional
76
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 24, 2013
CompletedFirst Posted
Study publicly available on registry
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedOctober 1, 2015
September 1, 2015
1 year
December 24, 2013
September 30, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Index of microcirculatory resistance (IMR) measured after successful coronary intervention
IMR will be immediately assessed after successful PCI patients within 48hr from admission
Secondary Outcomes (1)
wall motion score index on three month later TTE from index PCI
TTE will be assessed in all enrolled patients 3 month later from index PCI
Study Arms (2)
Clopidogrel
EXPERIMENTALClopidogrel 600mg loading
Ticagrelor
EXPERIMENTALTicagrelor 180mg loading
Interventions
Eligibility Criteria
You may qualify if:
- Males and Females
- between the ages of 18 and 75 years
- STEMI patients treated with percutaneous coronary intervention
- Able to provide informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Inha University Hospital
Incheon, Incheon, 400-711, South Korea
Related Publications (1)
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.
PMID: 24885437DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 24, 2013
First Posted
January 1, 2014
Study Start
October 1, 2013
Primary Completion
October 1, 2014
Study Completion
December 1, 2014
Last Updated
October 1, 2015
Record last verified: 2015-09