Anticoagulants; Circulating, Hemorrhagic DisorderPhase 4CACAODNCT02969746
Activates Charcoal for Patients Undergoing Invasive Procedure Delayed Due to Direct Oral Anticoagulants
A Phase 4 study testing Activated Charcoal in people with Anticoagulants; Circulating, Hemorrhagic Disorder, run by University Hospital, Angers at 6 sites in France.
Trial summary
This is a prospective, multicentric, randomized, open labeled superiority trial This study aims to evaluate the efficacy of oral activated charcoal for improving elimination of direct oral anticoagulants ( Rivaroxaban, Apixaban) in case of an unscheduled invasive procedure delayed to this anticoagulant treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulants; Circulating, Hemorrhagic Disorder
- What is being tested?
- Activated Charcoal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesFrance
- Study dates
- 18 Jul 2014to Sep 2024
- 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
- Patients under direct oral anticoagulant treatment (Apixaban, Rivaroxaban or Dabigatran)
- Age ≥18 years;
- Clinical condition needing a surgery or invasive procedure ( lumbar puncture, biopsy...), needing anticoagulant treatment interruption and intervention to be postponed
- Signed informed consent
Who cannot join
- Urgent immediate surgery without any possibility to wait for 24 hours
- contraindication for receiving oral treatment
- Active uncontrolled bleeding or bleeding in critical organ
- Hemodynamic instability, shock
- Known anticoagulant concentration < 50ng/mL
- drug intoxication
Show all 13Show fewer
- Fructose intolerance, glucose and galactose malabsorption syndrome, sucrase-isomaltase deficit
- Treated epileptic disease
- Pregnant or breast feeding
- Patient under guardianship
- No insurance cover
- Patient unable to give his consent
- Participation to another therapeutic trial
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Chu Angers
Angers, 49000
Chu Angers
Angers, 49933
CHU Clermont-ferrand
Cléron, 63000
CH Le MANS
Le Mans, 72000
CHU de Poitiers
Poitiers, 86000
CHU de St Etienne
Saint-Etienne, 42000
About this study
This is a prospective, multicentric, randomized, open labeled superiority trial
This study aims to evaluate the efficacy of oral activated charcoal for improving elimination of direct oral anticoagulants ( Rivaroxaban, Apixaban) in case of an unscheduled invasive procedure delayed to this anticoagulant treatment.
The primary outcome is the anticoagulant's half life. Plasma concentration will be measured by liquid chromatography-mass spectrometry for the main analysis (pharmacokinetic).
A total of 140 patients will randomly be assigned to the charcoal or control group, stratified according to their anticoagulant drug.
- Being tested
- Activated Charcoal
- Keywords
- activated charcoal, direct oral anticoagulant
- Medical subject headings
- Hemorrhagic Disorders, Anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activated CharcoalDrug
Patients will take oral activated charcoal after randomization in the intervention arm.
A blood sample(TO) will be collected after patient enrollment and before charcoal administration and 4 blood samples will be collected on a 8h length period (T1 to T4)
| Study group | Role | What they receive |
|---|---|---|
| Charcoal | Experimental | Patients will receive a single dose (20 gram) of oral activated charcoal Receives: Drug: Activated Charcoal |
| control | No intervention | Standard practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Direct Oral Anticoagulant half life
Measured: 0 to 8 hours
Secondary outcomes (3)
Time to obtain a plasmatic concentration lower than 50ng/mL
Measured: 0 to 8 hours
Rate of bleeding and/or thromboembolic complications after activated charcoal administration or not.
Measured: until Day 7
Number of patients with adverse events.
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study start18 Jul 2014
- Primary completionSep 2018
- Study completionSep 2024
Why it stopped: Feasibility issues, difficulties in the patient pathway, advances in knowledge
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anticoagulants; Circulating, Hemorrhagic DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Thomas Moumneh, Dr, Principal investigator, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969746
- Sponsor's protocol ID
- CACAOD
- Acronym
- CACAOD
- Status last verified
- Oct 2025
- First submitted
- 9 Nov 2016
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activates Charcoal for Patients Undergoing Invasive Procedure Delayed Due to Direct Oral Anticoagulants
- ClinicalTrials.gov ID
- NCT02969746
- Acronym / sponsor ID
- CACAOD / CACAOD
- Keywords
- activated charcoal, direct oral anticoagulant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Feasibility issues, difficulties in the patient pathway, advances in knowledge
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 18 Jul 2014 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2024 (actual)
- First posted
- 21 Nov 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.
This is a prospective, multicentric, randomized, open labeled superiority trial
This study aims to evaluate the efficacy of oral activated charcoal for improving elimination of direct oral anticoagulants ( Rivaroxaban, Apixaban) in case of an unscheduled invasive procedure delayed to this anticoagulant treatment.
The primary outcome is the anticoagulant's half life. Plasma concentration will be measured by liquid chromatography-mass spectrometry for the main analysis (pharmacokinetic).
A total of 140 patients will randomly be assigned to the charcoal or control group, stratified according to their anticoagulant drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Charcoal | Experimental | Drug: Activated CharcoalPatients will receive a single dose (20 gram) of oral activated charcoal |
| control | No intervention | –Standard practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients under direct oral anticoagulant treatment (Apixaban, Rivaroxaban or Dabigatran)
- Age ≥18 years;
- Clinical condition needing a surgery or invasive procedure ( lumbar puncture, biopsy...), needing anticoagulant treatment interruption and intervention to be postponed
- Signed informed consent
Key exclusion criteria (13 listed)
- Urgent immediate surgery without any possibility to wait for 24 hours
- contraindication for receiving oral treatment
- Active uncontrolled bleeding or bleeding in critical organ
- Hemodynamic instability, shock
- Known anticoagulant concentration < 50ng/mL
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 |
|---|---|---|
| Activated CharcoalPatients will take oral activated charcoal after randomization in the intervention arm. A blood sample(TO) will be collected after patient enrollment and before charcoal administration and 4 blood samples will be collected on a 8h length period (T1 to T4) | Drug | Charcoal |
Primary outcome
Direct Oral Anticoagulant half life
Time frame: 0 to 8 hours
3 secondary outcomes
Time to obtain a plasmatic concentration lower than 50ng/mL
Time frame: 0 to 8 hours
Rate of bleeding and/or thromboembolic complications after activated charcoal administration or not.
Time frame: until Day 7
Number of patients with adverse events.
Time frame: day 7
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Anticoagulants; Circulating, Hemorrhagic Disorder
Not yet recruiting
MEdication Counselling Models for Outpatient oRal antIcoaguLation
Anticoagulants; Circulating, Hemorrhagic Disorder
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.
Thomas Moumneh, Dr principal investigator
Sponsor GmbH
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Activated Charcoal in people with Anticoagulants; Circulating, Hemorrhagic Disorder, run by University Hospital, Angers at 6 sites 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 4 inclusion and 13 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: withdrawn, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
Direct Oral Anticoagulant half life (time frame: 0 to 8 hours). 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 7 Oct 2025.