Blood Coagulation TestsACTARDNCT02839434
Evaluation of the Interference of Antithrombotic Agents With Laboratory Monitoring of Heparin Therapy
An observational study of Blood Coagulation Tests, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Oral anticoagulants are increasingly prescribed and the are not discontinued for invasive cardiac procedures . Additional parenteral anticoagulation is necessary for these procedures (FA ablation and invasive coronary explorations). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Coagulation Tests
- What is being tested?
- Blood sample
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to 29 Jun 2018
- Phase
- Observational
- 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
Study population: Adult treated with oral anticoagulant at curative dose
Who may be able to join
- patient treated with oral anticoagulant at curative dose and requiring a requiring a venous blood sample for his management
Who cannot join
- opposition to the patient to participate to the study
Trial locations and contacts
1 site in 1 country.
About this study
Oral anticoagulants are increasingly prescribed and the are not discontinued for invasive cardiac procedures .
Additional parenteral anticoagulation is necessary for these procedures (FA ablation and invasive coronary explorations).
Read more
The unfractionated heparin doses are adapted on a monitoring test heparin, activated clotting time (ACT) with the aim of obtaining and maintaining an ACT > 300-400 sec. This goal is the same whether the patient is on oral anticoagulant treatment or not, and regardless of the initial level of anticoagulation.
The effects of oral anticoagulants on routine coagulation tests (PT, APTT, TT) are well documented, but few data have been published on the effects of heparin monitoring tests, particularly on the ACT.
The aim of this stuy is to redefine the target values of ACT and unfractionated heparin doses to administer to optimize the efficacy / safety of invasive procedures in cardiology.
- Conditions
- Blood Coagulation Tests
- Being tested
- Blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleProcedure or surgery
This blood sample does not require specific puncture because it is made on the occasion of a sample justified by the patient monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Treated with oral anticoagulants | Ex vivo study using blood samples from patients treated with oral anticoagulant (direct oral anticoagulants or AVK) at curative dose, taken in the usual cardiac monitoring. Receives: Procedure: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the plasmatic concentration in direct oral anticoagulants (DOAC) or International Normalized Ratio for AVK and the value of the Activated clotting time (ACT)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startDec 2015
- Primary completion29 Jun 2018
- Study completion29 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Coagulation TestsStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839434
- Sponsor's protocol ID
- AGR_2015_27
- Acronym
- ACTARD
- Status last verified
- Sep 2017
- First submitted
- 12 Jul 2016
- Last updated
- 18 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Interference of Antithrombotic Agents With Laboratory Monitoring of Heparin Therapy
- ClinicalTrials.gov ID
- NCT02839434
- Acronym / sponsor ID
- ACTARD / AGR_2015_27
- Conditions
- Blood Coagulation Tests
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Dec 2015 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 29 Jun 2018 (actual)
- First posted
- 21 Jul 2016 (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.
Oral anticoagulants are increasingly prescribed and the are not discontinued for invasive cardiac procedures .
Additional parenteral anticoagulation is necessary for these procedures (FA ablation and invasive coronary explorations).
The unfractionated heparin doses are adapted on a monitoring test heparin, activated clotting time (ACT) with the aim of obtaining and maintaining an ACT > 300-400 sec. This goal is the same whether the patient is on oral anticoagulant treatment or not, and regardless of the initial level of anticoagulation.
The effects of oral anticoagulants on routine coagulation tests (PT, APTT, TT) are well documented, but few data have been published on the effects of heparin monitoring tests, particularly on the ACT.
The aim of this stuy is to redefine the target values of ACT and unfractionated heparin doses to administer to optimize the efficacy / safety of invasive procedures in cardiology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated with oral anticoagulants | – | Procedure: Blood sampleEx vivo study using blood samples from patients treated with oral anticoagulant (direct oral anticoagulants or AVK) at curative dose, taken in the usual cardiac monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult treated with oral anticoagulant at curative dose
Key inclusion criteria (1 listed)
- patient treated with oral anticoagulant at curative dose and requiring a requiring a venous blood sample for his management
Key exclusion criteria (1 listed)
- opposition to the patient to participate to 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 |
|---|---|---|
| Blood sampleThis blood sample does not require specific puncture because it is made on the occasion of a sample justified by the patient monitoring. | Procedure or surgery | Treated with oral anticoagulants |
Primary outcome
Correlation between the plasmatic concentration in direct oral anticoagulants (DOAC) or International Normalized Ratio for AVK and the value of the Activated clotting time (ACT)
Time frame: 1 hour
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Coagulation Tests, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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: stopped early, as of the sponsor's last update on 18 Sep 2018. 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 France. 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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Correlation between the plasmatic concentration in direct oral anticoagulants (DOAC) or International Normalized Ratio for AVK and the value of the Activated clotting time (ACT) (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2018.