Platelet Inhibition in Patients With Systolic Heart Failure

NCT01765400 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 0574-11-FB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to determine if patients with systolic heart failure treated with prasugrel achieve greater platelet inhibition compared to those treated with clopidogrel.

Conditions

Systolic Heart Failure

Keywords

Heart failure; Antiplatelet therapy; Platelet aggregation; Clopidogrel; Prasugrel

Outcome Measures

Primary Outcomes (1)

• The Change in Platelet Aggregation Measured by the Accumetrics (VerifyNow P2Y12) Assay Between Baseline and Each Antiplatelet Medication

  Baseline, 2 weeks post clopidogrel, and 2 weeks post prasugrel, Change From Baseline at Week 2 Reported

Secondary Outcomes (2)

• The Change in Light Transmission Aggregometry (LTA)Between Baseline and Each Antiplatelet Medication

  Baseline, 2 weeks post clopidogrel, and 2 weeks post prasugrel

• The Change in Platelet Activation Assay (VASP)Between Baseline and Each Antiplatelet Medication

  Baseline, 2 weeks post clopidogrel, and 2 weeks post prasugrel

Study Arms (2)

Prasugrel

ACTIVE COMPARATOR

Prasugrel oral 10 mg once daily for 2 weeks

Drug: Prasugrel 10 mg daily x 2 weeks

Clopidogrel

ACTIVE COMPARATOR

Clopidogrel oral 75 mg once daily for 2 weeks

Drug: Clopidogrel 75 mg daily x 2 weeks

Interventions

Prasugrel 10 mg daily x 2 weeks DRUG

Prasugrel

Clopidogrel 75 mg daily x 2 weeks DRUG

Clopidogrel

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 19 to 74 years of age.
• Patients with a left ventricular ejection fraction \<35% by echocardiogram, SPECT myocardial perfusion study, cardiac MRI, cardiac computerized tomographic angiogram or invasive left ventricular angiogram within the last 6 months.
• Patients with NYHA Class III-IV heart failure at the time of enrollment.

You may not qualify if:

• Recent hospitalization within 30 days
• Patients expected to undergo major surgery or PCI in the next 30 days
• Patients taking clopidogrel, prasugrel, ticagrelor, ticlopidine, or cilostazol
• Patients listed for heart transplantation or having left ventricular assist device placement
• Patients with known allergy to either medication
• Patients with prior history of stroke or transient ischemic attack
• Patients with known intracranial neoplasm, aneurysm, or arteriovenous malformation
• Patients with a history of bleeding requiring hospitalization for treatment
• Patients taking oral anticoagulants
• Patients with body weight \<60 kg
• Women who are pregnant or breastfeeding
• Patients with hemoglobin \<10 mg/dl or platelet count \<100,000/ul at baseline
• Patients with known clotting or platelet disorders
• Patients with a baseline INR \> 1.4
• Patients with liver function tests (AST or ALT) \> 2 times normal

Sponsors & Collaborators

• University of Nebraska: lead
• Daiichi Sankyo: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

University of Nebaska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Heart Failure, Systolic; Heart Failure

Interventions

Prasugrel Hydrochloride; Clopidogrel

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ticlopidine; Thienopyridines; Pyridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Paul P Dobesh
• Organization: University of Nebraska Medical Center

pdobesh@unmc.edu

402-559-3982

Study Officials

• Paul P Dobesh, PharmD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: January 10, 2013
• Study Start: May 15, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 28, 2015
• Last Updated: October 10, 2023
• Results First Posted: November 30, 2022

Record last verified: 2023-09

Locations

US (1)