Ignite Creation Date:
2024-05-06 @ 3:50 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02389582
Status:
COMPLETED
Last Update Posted:
2016-04-29
First Post:
2014-12-04
Brief Title:
Effects of Low Molecular Weight Heparin Versus Dabigatran on Platelet Aggregation in Patients With Stable Coronary Artery Disease
Sponsor:
University of Sao Paulo General Hospital
Organization:
University of Sao Paulo General Hospital
Study Overview
Official Title:
Effects of LMWH Versus Dabigatran on Platelet Aggregation in Patients With Stable Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Anticoagulation with heparin is indicated in several situations such as acute coronary disease in combination with antiplatelet therapy for the prevention and treatment of venous thromboembolism and situations with high risk of thromboembolism Recently the latest trials on anticoagulation for stroke prevention on atrial fibrillation have shown an increased risk for acute mycardial infarction on patients submitted to new oral anticoagulants such as dabigatran The mechanism is still unclear however in this context some previous studies about interaction between anticoagulants mainly heparin and platelet aggregation have shown conflicting results while some suggest an inhibitory effect of heparin on platelet function others suggest that heparin could promote an increase in platelet activation The present study aims to assess the effects of the LMWH Enoxaparin and direct thrombin inhibitor Dabigatran on platelet aggregation studied and compared by different methods in patients with chronic coronary artery disease CAD
Detailed Description:
This is a prospective and open study We will include 29 patients with chronic CAD stable using ASA All patients will receive the same medications in effective doses recommended at each stage of the study so that every individual is his self-control the Enoxaparin will be administrated at a dose of 1mgkg twice a day and Dabigatran at a dose of 150mg twice a day Study Design Phase 1 There will be a first collection of blood samples from all patients at baseline for laboratory tests then the patient will receive Dabigatran for 5 days and laboratory tests including platelet aggregation will be made among others After a 30 days washout period enoxaparin will be administrated for 5 days and in the 6st day the same laboratory tests including platelet aggregation will be performed
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