Aspirin in Patients With Myocardial Infarction and Thrombocytopenia

NCT00501345 | Terminated Phase 3 Results

• 1 other identifier: ID01-674
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To determine the risk of bleeding from ASA therapy in thrombocytopenic patients who develop Acute Coronary Syndrome (ACS), and assess its effect on the overall morbidity and mortality in these patients as well as platelet functions.

Conditions

Thrombocytopenia; Myocardial Infarction

Keywords

Thrombocytopenia; Platelet Function; Acute Coronary Syndrome; Myocardial Infarction; Heart Attack; Aspirin

Outcome Measures

Primary Outcomes (1)

• Participants With 7 Days Observation Without Severe Bleeding

  Blood samples collected at baseline before or after aspirin is given and at 24 hours, 72 hours and 7 days after treatment has been initiated for those that remain in the study after the first 24 hours.

  7 Days

Study Arms (1)

Aspirin

EXPERIMENTAL

Drug: Aspirin

Interventions

Aspirin DRUG

325 mg by mouth on Day 1 only, followed by 160 mg by mouth daily

Aspirin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Presenting for Cardiology consult at M.D. Anderson Cancer Center.
• Platelet count between 100,000 and 20,000.
• Acute Coronary Syndrome diagnosed with their first 12 lead EKG.
• Patients that continue to show evidence of MI by cardiac enzymes with CPK levels \> 2 normal limits, CK-MB levels 10% above normal limits, and Troponin I levels \> 1.4ug/L will be considered positive for MI.
• Ability to give consent.

You may not qualify if:

• Contraindications to aspirin including severe intolerance or true allergy, active bleeding, hemophilia, active retinal bleeding, severe untreated hypertension, active peptic ulcer, or other significant source of gastrointestinal or genitourinary bleeding, brain metastasis, and altered mental status.
• Unwillingness or inability to give consent.
• Progressive heart failure, unstable angina not responding to medical therapy for 24 hours, or ventricular tachycardia, necessitating thrombolysis, and angioplasty.
• Patients that rule out for MI by cardiac enzymes panel after the first 24 hours.
• Patients that rule in for MI and have Platelet count \> 100,000.
• Patients with platelet count \< 20,000.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas M.D.Anderson Cancer Center

MeSH Terms

Conditions

Thrombocytopenia; Myocardial Infarction; Acute Coronary Syndrome

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

A change in hospital practice where patients with thrombocytopenia now routinely receive aspirin for acute coronary syndromes makes it difficult to obtain a baseline thromboelastogram.

Results Point of Contact

• Title: Jean-Bernard Durand, MD / Professor
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Jean-Bernard Durand, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2007
• First Posted: July 16, 2007
• Study Start: February 1, 2002
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: August 1, 2012
• Results First Posted: October 13, 2010

Record last verified: 2012-07

Locations

US (1)