Antiplatelet Therapy Guided by Thrombelastography in Patients With Acute Coronary Syndromes (TEGCOR Study)

NCT01612884 | Terminated Phase 4 Results

• 1 other identifier: 1106005745
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 2

Brief Summary

Personalized treatment approaches and antiplatelet drug choice have been proposed to optimize safety of coronary stenting by reducing heart attacks and repeat interventions while simultaneously minimizing adverse bleeding events. This study compares the efficacy of two laboratory guided treatment algorithms to personalize antiplatelet medication choice after coronary stenting

Conditions

Thrombosis; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Thrombelastography (TEG) MA

  Persistence of high tensile clot strength measured by TEG 16-24 hours after reloading of either clopidogrel or prasugrel

  1 day

Secondary Outcomes (2)

• Number of Participants With Ischemic Events

  6 months

• Number of Participants With Bleeding Events

  6 months

Study Arms (2)

TEG

OTHER

Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA\<69

Drug: Prasugrel; Drug: Clopidogrel

Light transmittance aggregometry

OTHER

Clopidogrel non-response defined as MPA ADP \>42.9% Clopidogrel response defined as MPA ADP \<42.9%

Drug: Prasugrel; Drug: Clopidogrel

Interventions

Prasugrel DRUG

Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder

Light transmittance aggregometry; TEG

Clopidogrel DRUG

Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder

Light transmittance aggregometry; TEG

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted with acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction) and referred for coronary angiography.
• Current therapy with clopidogrel (at least 300mg loading dose, or 75mg po daily for \>5 days)
• Age range 21-75 years.

You may not qualify if:

• Unable to give consent
• Age younger than 21 years, greater than 75 years
• History of stroke
• Body weight \<60 kg
• Acute STEMI,
• Thrombocytopenia\<100'000,
• requirement for chronic warfarin therapy

Sponsors & Collaborators

• Indiana University: lead

Study Sites (2)

Eskenazi Health

Indianapolis, Indiana, 46202, United States

Location

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Thrombosis; Coronary Artery Disease

Interventions

Prasugrel Hydrochloride; Clopidogrel

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive 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: Rolf Kreutz, MD
• Organization: Indiana University School of Medicine

rkreutz@iu.edu

3179620500

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Associate Professor of Clinical Medicine

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: June 6, 2012
• Study Start: August 1, 2011
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 26, 2018
• Results First Posted: April 26, 2018

Record last verified: 2018-03

Locations

US (2)