Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00501345
Status:
TERMINATED
Last Update Posted:
2012-08-01
First Post:
2007-07-13
Brief Title:
Aspirin in Patients With Myocardial Infarction and Thrombocytopenia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Effects of Aspirin on Platelet Function and Clinical Outcome in Patients With Thrombocytopenia Neoplasm and Myocardial Infarction
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual study terminated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 100000 and 20000 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 100000 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 20000 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
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 100000 and 20000 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 100000 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 20000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None