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Comparing Ticagrelor and Clopidogrel Pharmacodynamics After Thrombolysis

NCT02048085 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2018-04-04

No results posted yet for this study

Summary

This study involves doing platelet function testing in patients who have undergone fibrinolysis. Fibrinolysis (Use of clot busting medicine in heart attack) is the standard of care to restore blood flow in blocked arteries as soon as possible after the "Heart attack" in rural health center where access to cardiac catheterization is one hour away. Fibrinolysis is done by the emergency room physician in a timely fashion to minimize the damage of the myocardium. Additionally anti-platelet regimen as adjuvant for patient undergoing fibrinolysis has been well studied in many trials. In this study investigators will use clopidogrel or ticagrelor in randomized fashion to evaluate anti- platelet effect by measuring efficacy in vivo (pharmacodynamics) and blood levels of both drugs (Pharmacokinetics).

Conditions

  • Acute ST Segment Elevation Myocardial Infarction
  • Acute Coronary Syndrome

Interventions

DRUG

Ticagrelor

For ticagrelor arm, randomized STEMI patients with a history of fibrinolysis within last 24-48 and undergoing PCI will be loaded with ticagrelor 180 mg prior to PCI followed by maintenance dose of 90 mg bid.

DRUG

Clopidogrel

For clopdigrel arm, randomized STEMI patients with a history of fibrinolysis within last 24-48 and undergoing PCI will be loaded with clopidogrel 300 mg prior to PCI followed by maintenance dose of 75 mg QD

Sponsors & Collaborators

  • Medical Center of South Arkansas

    lead OTHER

Principal Investigators

  • Rakesh K Sharma, MD, FACC, FSCAI, FSCCT · Medical Center of South Arkansas

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-02
Primary Completion
2015-05-31
Completion
2018-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02048085 on ClinicalTrials.gov