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Effects of Aspirin on Platelet Function and Clinical Outcome in Patients With Thrombocytopenia, Neoplasm, and Myocardial Infarction


Phase 3
N/A
N/A
Not Enrolling
Both
Thrombocytopenia, Myocardial Infarction

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Trial Information

Effects of Aspirin on Platelet Function and Clinical Outcome in Patients With Thrombocytopenia, Neoplasm, and Myocardial Infarction


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Participants With 7 Days Observation Without Severe Bleeding

Outcome Description:

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.

Outcome Time Frame:

7 Days

Safety Issue:

No

Principal Investigator

Jean-Bernard Durand, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

ID01-674

NCT ID:

NCT00501345

Start Date:

February 2002

Completion Date:

February 2008

Related Keywords:

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

Name

Location
U.T.M.D. Anderson Cancer Center Houston, Texas  77030