Comparing Ticagrelor and Clopidogrel Pharmacodynamics After Thrombolysis

NCT02048085 | Withdrawn Phase 4

• 1 other identifier: ISSBRIL0224
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ACS; STEMI; Fibrinolysis; Pharmacodynamics; Pharmacokinetics; Plavix; Brilinta; Ticagrelor; Clopidogrel

Outcome Measures

Primary Outcomes (1)

• Pharmacodynamics (PRU and IPA) of ticagrelor vs Clopidogrel using VASP and VerifyNow

  Pharmacodynamics at baseline, 30 min, 60 min, 120 min, 4 hours, 8 hours and at 24 hours

  Change from baseline at 2 hours

Secondary Outcomes (1)

• Pharmacokinetic (AUC, Cmax, Tmax)

  Change from baseline at 2 hours

Study Arms (2)

Ticagrelor

EXPERIMENTAL

Ticagrelor Arm will be dosed with a loading dose of 180 mg followed by maintenance dose of 90 mg BID until discharge or up to 8 days.

Drug: Ticagrelor

Clopidogrel

ACTIVE COMPARATOR

Clopidogrel arm will be dose with a loading dose of 300 mg followed by maintenance dose of 75 mg everyday until discharge or up to 8 days.

Drug: Clopidogrel

Interventions

Ticagrelor DRUG

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.

Also known as: Brilinta

Ticagrelor

Clopidogrel DRUG

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

Also known as: Plavix

Clopidogrel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 18 to 75 years of age
• Ischemic discomfort lasting more than 20 mins at rest within 12 hours before randomization
• ST-segment elevation of at least 0.1 mV in at least two contiguous limb leads, ST-segment elevation of at least 0.2 mV in at least two contiguous precordial leads, or left bundle-branch block that was not known to be old
• Received fibrinolytic agent, an anticoagulant (if a fibrin-specific lytic agent was prescribed) and aspirin within 24-48 hours

You may not qualify if:

• Hypersensitivity to ticagrelor or clopidogrel
• Active Pathological Bleeding or history of intracranial bleeding
• Concomitant use of oral anticoagulant
• Concomitant use of 40 mg of Simvastatin or lovastatin
• Concomitant strong CYP3A inhibitors such as ketoconazole, clarithromycin, nefazadone, ritonavir, atazanavir
• Concomitant use of CYP2C19 inhibitors such as omeprazole or esomeprazole
• Patients planned to urgent CABG
• Thrombocytopenia
• Dialysis
• Use of oral antiplatelet agent (ticagrelor, prasugrel, Clopidogrel) within 7 days prior to enrollment
• Use of GP IIb/IIIa inhibitors
• Rescue PCI (PCI \< 24 hours from symptom onset) -

Sponsors & Collaborators

• Medical Center of South Arkansas: lead

Study Sites (1)

Medical Center of South Arkansas

El Dorado, Arkansas, 71730, United States

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Acute Coronary Syndrome

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Rakesh K Sharma, MD, FACC, FSCAI, FSCCT

  Medical Center of South Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Medicine, Adjunct Clinical Professor of Medicine and Cardiology

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: January 29, 2014
• Study Start: January 2, 2014
• Primary Completion: May 1, 2015
• Study Completion: March 1, 2018
• Last Updated: April 4, 2018

Record last verified: 2018-04

Locations

US (1)