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Effects of Low Molecular Weight Heparin Versus Dabigatran on Platelet Aggregation in Patients With Stable Coronary Artery Disease

Primary Purpose

Coronary Disease

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Dabigatran

Enoxaparin

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring platelet function; dabigatran;enoxaparin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age > 18 years old Coronary artery disease, defined as previous myocardial infarction and/or coronary angioplasty and/or Coronary Artery Bypass Graft (CABG) surgery and/or coronariography showing obstruction of at least 50 % in one of major epicardial vessels Treatment with Acetylsalicylic Acid (ASA) 100 mg/day

Exclusion Criteria:

Use in the last 7 days of oral anticoagulant or any other antiplatelet drug beside ASA Active bleeding Pregnancy or woman of childbearing age without contraceptive method Hemoglobin < 10 g/dL or hematocrit < 30 %, hematocrit > 50 %, platelets < 100.000/mm3 or > 500.000/mm3; creatinin clearance < 50 ml/minute Percutaneous coronary intervention (PCI) on the last 30 days before randomization (or PCI on the last year when drug-eluted stents are used); CABG surgery on the last 90 days; acute coronary syndrome on the last 60 days Active malignant neoplasm Active peptic ulcer disease on the last 60 days or upper gastrointestinal bleeding any time in life Refuse to participate in the study

Sites / Locations

InCor Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dabigatran

Enoxaparin

Arm Description

Dabigatran 150mg twice a day for five days

Enoxaparin 1mg/kg/day twice a day for five days

Outcomes

Primary Outcome Measures

Change from Baseline Platelet Aggregability

Comparing PLATELET AGGREGABILITY values through Multiplate test between patients on aspirin, assigned to the groups dabigatran and enoxaparin.

Secondary Outcome Measures

Change from Baseline Platelet Aggregability with other aggregability test

Comparing PLATELET AGGREGABILITY values through Verify Now test (units=ARU) between patients on aspirin assigned to the groups dabigatran and enoxaparin

Full Information

NCT ID

NCT02389582

First Posted

December 4, 2014

Last Updated

April 28, 2016

Sponsor

University of Sao Paulo General Hospital

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT02389582

Brief Title

Effects of Low Molecular Weight Heparin Versus Dabigatran on Platelet Aggregation in Patients With Stable Coronary Artery Disease

Official Title

Effects of LMWH Versus Dabigatran on Platelet Aggregation in Patients With Stable Coronary Artery Disease

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Sao Paulo General Hospital

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee

5. Study Description

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 1mg/kg 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Disease

Keywords

platelet function; dabigatran;enoxaparin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dabigatran

Arm Type

Experimental

Arm Description

Dabigatran 150mg twice a day for five days

Arm Title

Enoxaparin

Arm Type

Active Comparator

Arm Description

Enoxaparin 1mg/kg/day twice a day for five days

Intervention Type

Drug

Intervention Name(s)

Dabigatran

Other Intervention Name(s)

Pradaxa

Intervention Description

Use for 5 days

Intervention Type

Drug

Intervention Name(s)

Enoxaparin

Other Intervention Name(s)

Clexane

Intervention Description

Use for 5 days

Primary Outcome Measure Information:

Title

Change from Baseline Platelet Aggregability

Description

Comparing PLATELET AGGREGABILITY values through Multiplate test between patients on aspirin, assigned to the groups dabigatran and enoxaparin.

Time Frame

5 days after starting the drug

Secondary Outcome Measure Information:

Title

Change from Baseline Platelet Aggregability with other aggregability test

Description

Comparing PLATELET AGGREGABILITY values through Verify Now test (units=ARU) between patients on aspirin assigned to the groups dabigatran and enoxaparin

Time Frame

5 days after starting the drug

Other Pre-specified Outcome Measures:

Title

Comparing the main outcome on pre-specified subgroups

Description

elderly (age > 65 yrs-old) versus non-elderly male versus female smoking versus non-smoking patients diabetic versus non-diabetic

Time Frame

5 days after starting the drug

Title

Correlate platelet aggregability and inflammation markers

Time Frame

5 days after starting the drug

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age > 18 years old Coronary artery disease, defined as previous myocardial infarction and/or coronary angioplasty and/or Coronary Artery Bypass Graft (CABG) surgery and/or coronariography showing obstruction of at least 50 % in one of major epicardial vessels Treatment with Acetylsalicylic Acid (ASA) 100 mg/day Exclusion Criteria: Use in the last 7 days of oral anticoagulant or any other antiplatelet drug beside ASA Active bleeding Pregnancy or woman of childbearing age without contraceptive method Hemoglobin < 10 g/dL or hematocrit < 30 %, hematocrit > 50 %, platelets < 100.000/mm3 or > 500.000/mm3; creatinin clearance < 50 ml/minute Percutaneous coronary intervention (PCI) on the last 30 days before randomization (or PCI on the last year when drug-eluted stents are used); CABG surgery on the last 90 days; acute coronary syndrome on the last 60 days Active malignant neoplasm Active peptic ulcer disease on the last 60 days or upper gastrointestinal bleeding any time in life Refuse to participate in the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

José C Nicolau, PhD

Organizational Affiliation

InCor Heart Institute - University of São Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

InCor Heart Institute

City

São Paulo

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

31758517

Citation

Arantes FBB, Menezes FR, Franci A, Barbosa CJDG, Dalcoquio TF, Nakashima CAK, Baracioli LM, Furtado RHM, Nomelini QSS, Ramires JAF, Kalil Filho R, Nicolau JC. Influence of Direct Thrombin Inhibitor and Low Molecular Weight Heparin on Platelet Function in Patients with Coronary Artery Disease: A Prospective Interventional Trial. Adv Ther. 2020 Jan;37(1):420-430. doi: 10.1007/s12325-019-01153-8. Epub 2019 Nov 22.

Results Reference

derived

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Effects of Low Molecular Weight Heparin Versus Dabigatran on Platelet Aggregation in Patients With Stable Coronary Artery Disease

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