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

Phase 4

Completed

• Conditions: Non-ST Segment Elevation Myocardial Infarction; ST Segment Elevation Myocardial Infarction
• Interventions: Drug: Clopidogrel; Drug: Ticagrelor

• Registration Number: NCT02026219
• Lead Sponsor: Inha University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-12-24
• Study First Submitted QC: 2013-12-30
• Study First Posted: 2014-01-01
• Primary Completion: 2014-10
• Study Completion: 2014-12
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-30
• Last Update Posted: 2015-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clopidogrel	Clopidogrel	Clopidogrel 600mg loading
Ticagrelor	Ticagrelor	Ticagrelor 180mg loading

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of