Ischemic Heart DiseaseINTERMITTENTNCT04151680
Anticoagulation on Demand After Percutaneous Coronary Intervention in High Bleeding Risk Patients
An observational study of Ischemic Heart Disease and Atrial Fibrillation, run by University of Roma La Sapienza at 2 sites in Italy.
Trial summary
Preliminary experiences suggest that intermittent anticoagulation guided by continuous electrocardiographic monitoring can reduce the incidence of bleeding in patients with episodes of atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease, Atrial Fibrillation
- What is being tested?
- Intermittent administration of dabigatran, rivaroxaban, apixaban, or edoxaban and Chronic administration of dabigatran, rivaroxaban, apixaban, or edoxaban
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Dec 2019to 30 Nov 2023
- How long will I take part?
- 12 Months
- 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: High bleeding risk (HBR) patients undergoing percutaneous coronary angiography with history of paroxysmal atrial fibrillation
Who may be able to join
- No chronic atrial fibrillation
- Coronary artery disease
- Percutaneous coronary intervention
Who cannot join
- Contraindications to anticoagulation
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
San Raffaele Pisana
Rome, 00100
Giuseppe Marazzi, MD, +39 335 8381320, giuseppe.marazzi@yahoo.com
- Recruiting
Sapienza University
Rome, 00161
Francesco Pelliccia, MD, 064997 ext. 123, f.pelliccia@mclink.it
Francesco Pelliccia, MD
About this study
Official title: Safety and Efficacy of Anticoagulation on Demand After Percutaneous Coronary Intervention in High Bleeding Risk (HBR) Patients With History of Paroxysmal Atrial Fibrillation
Preliminary experiences suggest that intermittent anticoagulation guided by continuous electrocardiographic monitoring can reduce the incidence of bleeding in patients with episodes of atrial fibrillation.
Uncertainty about the potential implications of a strategy of intermittent anticoagulation after percutaneous coronary intervention exists.
The investigators will perform a case-control study to evaluate the safety and efficacy of anticoagulation on demand in high bleeding risk (HBR) patients with paroxysmal atrial fibrillation after percutaneous coronary intervention.
Read the detailed description
For decades now, stroke prevention in patients with atrial fibrillation has largely consisted of chronic oral anticoagulation, often with no end in sight. This strategy, however, is associate with a high incidence of bleeding complications, especially when anticoagulation is associated with antiplatelet agents, as it occurs in patients with coronary artery disease undergoing percutaneous coronary intervention.
Known as intermittent, on demand, or 'pill in the pocket' anticoagulation, the strategy of prescribing oral anticoagulation only when is actually needed, has gotten a feasibility boost from recent advancements in both medical therapy and rhythm monitoring technology.
Preliminary experiences suggest that intermittent anticoagulation guided by continuous electrocardiographic monitoring can reduce the incidence of bleeding in patients with episodes of atrial fibrillation.
Uncertainty about the potential implications of a strategy of intermittent anticoagulation after percutaneous coronary intervention exists.
The investigators will perform a case-control study to evaluate the safety and efficacy of anticoagulation on demand in high bleeding risk (HBR) patients with paroxysmal atrial fibrillation after percutaneous coronary intervention.
- Conditions
- Ischemic Heart Disease, Atrial Fibrillation
- Being tested
- Intermittent administration of dabigatran, rivaroxaban, apixaban, or edoxaban, Chronic administration of dabigatran, rivaroxaban, apixaban, or edoxaban
- Keywords
- coronary artery disease
- Medical subject headings
- Myocardial Ischemia, Atrial Fibrillation, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent administration of dabigatran, rivaroxaban, apixaban, or edoxabanDrug
Also called INTERMITTENT GROUP
Patients will receive intermittent treatment with a novel oral anticoagulant drug
Chronic administration of dabigatran, rivaroxaban, apixaban, or edoxabanDrug
Also called CHRONIC GROUP
Patients will receive chronic treatment with a novel oral anticoagulant drug
| Study group | Role | What they receive |
|---|---|---|
| Intermittent anticoagulation | Patients receiving anticoagulation only if continuous electrocardiographic monitoring detects an atrial fibrillation episode Receives: Drug: Intermittent administration of dabigatran, rivaroxaban, apixaban, or edoxaban | |
| Chronic anticoagulation | Patients receiving chronic oral anticoagulation regardless findings at continuous electrocardiographic monitoring Receives: Drug: Chronic administration of dabigatran, rivaroxaban, apixaban, or edoxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Outcome Event (MACE)
The time to final occurrence of cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia driven revascularization
Measured: Up to 1 year
Days on anticoagulant treatment
The total number of days on anticoagulant treatment
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Dec 2019
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Pelliccia, University of Roma La Sapienza
- Investigators
- Carlo Gaudio, MD, Study director, University Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151680
- Sponsor's protocol ID
- 2019/D/983
- Acronym
- INTERMITTENT
- Status last verified
- Sep 2022
- First submitted
- 30 Oct 2019
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Anticoagulation on Demand After Percutaneous Coronary Intervention in High Bleeding Risk (HBR) Patients With History of Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04151680
- Acronym / sponsor ID
- INTERMITTENT / 2019/D/983
- Conditions
- Ischemic Heart Disease, Atrial Fibrillation
- Keywords
- coronary artery disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 5 Nov 2019 (actual)
- 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.
Preliminary experiences suggest that intermittent anticoagulation guided by continuous electrocardiographic monitoring can reduce the incidence of bleeding in patients with episodes of atrial fibrillation.
Uncertainty about the potential implications of a strategy of intermittent anticoagulation after percutaneous coronary intervention exists.
The investigators will perform a case-control study to evaluate the safety and efficacy of anticoagulation on demand in high bleeding risk (HBR) patients with paroxysmal atrial fibrillation after percutaneous coronary intervention.
Detailed description
For decades now, stroke prevention in patients with atrial fibrillation has largely consisted of chronic oral anticoagulation, often with no end in sight. This strategy, however, is associate with a high incidence of bleeding complications, especially when anticoagulation is associated with antiplatelet agents, as it occurs in patients with coronary artery disease undergoing percutaneous coronary intervention.
Known as intermittent, on demand, or 'pill in the pocket' anticoagulation, the strategy of prescribing oral anticoagulation only when is actually needed, has gotten a feasibility boost from recent advancements in both medical therapy and rhythm monitoring technology.
Preliminary experiences suggest that intermittent anticoagulation guided by continuous electrocardiographic monitoring can reduce the incidence of bleeding in patients with episodes of atrial fibrillation.
Uncertainty about the potential implications of a strategy of intermittent anticoagulation after percutaneous coronary intervention exists.
The investigators will perform a case-control study to evaluate the safety and efficacy of anticoagulation on demand in high bleeding risk (HBR) patients with paroxysmal atrial fibrillation after percutaneous coronary intervention.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent anticoagulation | – | Drug: Intermittent administration of dabigatran, rivaroxaban, apixaban, or edoxabanPatients receiving anticoagulation only if continuous electrocardiographic monitoring detects an atrial fibrillation episode |
| Chronic anticoagulation | – | Drug: Chronic administration of dabigatran, rivaroxaban, apixaban, or edoxabanPatients receiving chronic oral anticoagulation regardless findings at continuous electrocardiographic monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- High bleeding risk (HBR) patients undergoing percutaneous coronary angiography with history of paroxysmal atrial fibrillation
Key inclusion criteria (3 listed)
- No chronic atrial fibrillation
- Coronary artery disease
- Percutaneous coronary intervention
Key exclusion criteria (2 listed)
- Contraindications to anticoagulation
- Pregnancy
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 |
|---|---|---|
| Intermittent administration of dabigatran, rivaroxaban, apixaban, or edoxabanAlso: INTERMITTENT GROUPPatients will receive intermittent treatment with a novel oral anticoagulant drug | Drug | Intermittent anticoagulation |
| Chronic administration of dabigatran, rivaroxaban, apixaban, or edoxabanAlso: CHRONIC GROUPPatients will receive chronic treatment with a novel oral anticoagulant drug | Drug | Chronic anticoagulation |
Primary outcome
Major Adverse Outcome Event (MACE)
Time frame: Up to 1 year
The time to final occurrence of cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia driven revascularization
Days on anticoagulant treatment
Time frame: Up to 1 year
The total number of days on anticoagulant treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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.
Carlo Gaudio, MD study director
University Sapienza
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease and Atrial Fibrillation, run by University of Roma La Sapienza at 2 sites in Italy.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Pelliccia, MD (+390649971, f.pelliccia@mclink.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Outcome Event (MACE) (time frame: Up to 1 year). The study lists 2 primary outcomes in all. 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 9 Sep 2022.