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Aspirin in Patients With Myocardial Infarction and Thrombocytopenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00501345
Recruitment Status : Terminated (Low accrual, study terminated.)
First Posted : July 16, 2007
Results First Posted : October 13, 2010
Last Update Posted : August 1, 2012
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Thrombocytopenia Myocardial Infarction Drug: Aspirin Phase 3

Detailed Description:

Aspirin is known to decrease death rate by as much as 50% in patients that suffer from heart attacks. Patients with low platelet count are not given aspirin for fear of an increased risk of bleeding. Researchers want to compare the risks versus the benefits of using aspirin in this patient population.

Participants in this study who suffer chest pain will be treated with a single enteric coated aspirin 325 mg instead of the current treatment without aspirin. Participants will then be tested to confirm that they had a heart attack by EKG (a test to measure the electrical activity of the heart) and blood tests (5ml of blood) will be drawn every 8 hours to detect enzymes that are released from the heart due to the heart attack. Blood samples will also be examined for platelet number.

Participants who are found to have had a heart attack and have a platelet count of between 100,000 and 20,000 will be continued on aspirin (160 mg per day). All other standard medications for heart attacks will also be given.

Participants who are found to have had a heart attack but whose platelet number is more than 100,000 will be given the standard therapy for heart attack, including enteric coated aspirin 325 mg per day, and will no longer take part in this study. Participants who are found to have had a heart attack but whose platelet number is less than 20,000 will be not be included in the study and will be treated as deemed appropriate by their primary physician.

Participants will be examined daily and evaluated for bleeding. Blood samples (30 ml of blood) will also be drawn before or after aspirin is given and 24 hours, 72 hours and 7 days after aspirin treatment to study platelet function. Participants will be followed up on the study for 7 days. Participants will be followed up in the cardiology clinic within 1-2 weeks after discharge from the hospital, then once a month for six month. Further follow up will be every 6 month. Patients are requested to follow up with cardiology by phone at any time for any bleeding.

Participants who are not found to have had a heart attack will not receive any further aspirin treatment.

This is an investigational study. Aspirin is an FDA approved drug for treatment of heart attacks and is commercially available. Aspirin is a standard therapy for patients who have had a heart attack. Thirty patients will take part in this study. All will be enrolled at M. D. Anderson.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Aspirin on Platelet Function and Clinical Outcome in Patients With Thrombocytopenia, Neoplasm, and Myocardial Infarction
Study Start Date : February 2002
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Aspirin Drug: Aspirin
325 mg by mouth on Day 1 only, followed by 160 mg by mouth daily

Primary Outcome Measures :
  1. Participants With 7 Days Observation Without Severe Bleeding [ Time Frame: 7 Days ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Presenting for Cardiology consult at M.D. Anderson Cancer Center.
  2. Platelet count between 100,000 and 20,000.
  3. Acute Coronary Syndrome diagnosed with their first 12 lead EKG.
  4. 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.
  5. Ability to give consent.

Exclusion Criteria:

  1. 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.
  2. Unwillingness or inability to give consent.
  3. Progressive heart failure, unstable angina not responding to medical therapy for 24 hours, or ventricular tachycardia, necessitating thrombolysis, and angioplasty.
  4. Patients that rule out for MI by cardiac enzymes panel after the first 24 hours.
  5. Patients that rule in for MI and have Platelet count > 100,000.
  6. Patients with platelet count < 20,000.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00501345

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United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Jean-Bernard Durand, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00501345    
Other Study ID Numbers: ID01-674
First Posted: July 16, 2007    Key Record Dates
Results First Posted: October 13, 2010
Last Update Posted: August 1, 2012
Last Verified: July 2012
Keywords provided by M.D. Anderson Cancer Center:
Platelet Function
Acute Coronary Syndrome
Myocardial Infarction
Heart Attack
Additional relevant MeSH terms:
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Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Blood Platelet Disorders
Hematologic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors