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Low accrual, study terminated.
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | 325 mg by mouth on Day 1 only, followed by 160 mg by mouth daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Bernard Durand, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.T.M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| The University of Texas M.D.Anderson Cancer Center | View source |
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Study terminated as a result of difficulty in accrual of candidate patients for enrollment. Six patients were enrolled but one patient did not meet eligibility criteria.
Recruitment Period: 02/28/02 through 04/22/04. All participants recruited at UT MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aspirin | 325 mg by mouth Day 1, 160 mg daily thereafter |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aspirin | 325 mg by mouth Day 1, 160 mg daily thereafter |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The baseline Thromboelastogram showed normal platelet function in all patients and no evidence of heparin induced thrombocytopenia (HIT). No further analysis was done as study was terminated due to lack of accrual. | Posted | 7 Days |
|
|
2 Years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aspirin | 325 mg by mouth Day 1, 160 mg daily thereafter |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean-Bernard Durand, MD / Professor | UT MD Anderson Cancer Center | CR_Study_Registration@mdanderson.org |
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| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| D009203 | Myocardial Infarction |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
| 0 |
| 0 |
| 0 |
| 0 |
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| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |