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

ST Segment Elevation Myocardial Infarction Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02026219
• Other study ID #: IUH-IRB-13-2256
• Status: Completed
• Phase: Phase 4
• First received: December 24, 2013
• Last updated: September 30, 2015
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: September 2015
• Source: Inha University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

• 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Clopidogrel
Clopidogrel 600mg loading
• Ticagrelor
Ticagrelor 180mg loading

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Inha University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Index of microcirculatory resistance (IMR) measured after successful coronary intervention		IMR will be immediately assessed after successful PCI patients within 48hr from admission	No
Secondary	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	No