Coronary DiseasePhase 4NCT02389582
Effects of Low Molecular Weight Heparin Versus Dabigatran on Platelet Aggregation in Patients With Stable Coronary Artery Disease
A Phase 4 study testing Dabigatran and Enoxaparin in people with Coronary Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Dabigatran and Enoxaparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteBrazil
- Study dates
- May 2014to Nov 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of LMWH Versus Dabigatran on Platelet Aggregation in Patients With Stable Coronary Artery Disease
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).
Read the 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.
- Conditions
- Coronary Disease
- Being tested
- Dabigatran, Enoxaparin
- Keywords
- platelet function; dabigatran;enoxaparin
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DabigatranDrug
Also called Pradaxa
Use for 5 days
EnoxaparinDrug
Also called Clexane
Use for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Dabigatran | Experimental | Dabigatran 150mg twice a day for five days Receives: Drug: Dabigatran |
| Enoxaparin | Active comparator | Enoxaparin 1mg/kg/day twice a day for five days Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Platelet Aggregability
Comparing PLATELET AGGREGABILITY values through Multiplate test between patients on aspirin, assigned to the groups dabigatran and enoxaparin.
Measured: 5 days after starting the drug
Secondary outcomes (1)
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
Measured: 5 days after starting the drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMay 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
- Investigators
- José C Nicolau, PhD, Principal investigator, InCor Heart Institute - University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389582
- Sponsor's protocol ID
- SDC 3877/13/002
- Status last verified
- Aug 2014
- First submitted
- 4 Dec 2014
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31758517
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of LMWH Versus Dabigatran on Platelet Aggregation in Patients With Stable Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02389582
- Acronym / sponsor ID
- SDC 3877/13/002
- Conditions
- Coronary Disease
- Keywords
- platelet function; dabigatran;enoxaparin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- May 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dabigatran | Experimental | Drug: DabigatranDabigatran 150mg twice a day for five days |
| Enoxaparin | Active comparator | Drug: EnoxaparinEnoxaparin 1mg/kg/day twice a day for five days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DabigatranAlso: PradaxaUse for 5 days | Drug | Dabigatran |
| EnoxaparinAlso: ClexaneUse for 5 days | Drug | Enoxaparin |
Primary outcome
Change from Baseline Platelet Aggregability
Time frame: 5 days after starting the drug
Comparing PLATELET AGGREGABILITY values through Multiplate test between patients on aspirin, assigned to the groups dabigatran and enoxaparin.
1 secondary outcome
Change from Baseline Platelet Aggregability with other aggregability test
Time frame: 5 days after starting the drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
- Derived from this study: PubMed 31758517Arantes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José C Nicolau, PhD principal investigator
InCor Heart Institute - University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dabigatran and Enoxaparin in people with Coronary Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Platelet Aggregability (time frame: 5 days after starting the drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02389582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2016; AzTrials last refreshed its copy on 8 Nov 2026.