Atrial FibrillationPhase 4MUSICA-2NCT01141153
Anticoagulation in Stent Intervention
A Phase 4 study testing Acetylsalicylic Acid + clopidogrel + acenocoumarol and Acetylsalicylic Acid + clopidogrel in people with Atrial Fibrillation and Stroke, run by Hospital Universitari Vall d'Hebron Research Institute at 11 sites in Spain.
Trial summary
Objective: The main objective is to evaluate the pattern of dual antiplatelet therapy (aspirin, 300 mg / day + clopidogrel 75 mg / day) compared to the use of the triple regimen (Acenocoumarol as control + acetylsalicylic acid 100 mg / day + Clopidogrel 75 mg / day) in patients with atrial fibrillation, low-moderate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke
- What is being tested?
- Acetylsalicylic Acid + clopidogrel + acenocoumarol and Acetylsalicylic Acid + clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 11 sitesSpain
- Study dates
- Jun 2010to Dec 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
- Patients of both sexes older than 18 years.
- Patients with permanent atrial fibrillation, persistent or paroxysmal (at least one episode), documented electrocardiographically and receiving oral anticoagulation. Patients with acute coronary syndrome or stable angina who are undergoing PCI-S.
- Patients who have previously given their informed consent to participation in the study.
Who cannot join
- Patients who can not be followed by the research team during the 12 months provided for monitoring.
- Patients with renal failure or serum creatinine above 2 mg • dL-1, neurological deficits, active ulcer or epigastric pain.
- Patients who continue regular treatment with NSAIDs or other analgesics or corticosteroids.
- Patients undergoing reoperation.
- Patients who during the study period, should receive, according to medical criteria, other adjuvant drug treatment than that specified in this protocol.
- Pregnant women.
Show all 11Show fewer
- Use of investigational agents or not registered within 30 days of entry into the study.
- Patients with a history of allergy to study drugs or excipients.
- Patients with severe valve disease.
- Patients with CHADS> 2.
- Patients who can not use the study drug orally.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Spain11 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Sant Pau
Barcelona, Barcelona, 08025
Hospital Universitario Vall d'Hebron
Barcelona, Barcelona, 08035
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital Dr.Josep Trueta
Girona, Girona, 17007
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Universitario Gregorio Marañón
Madrid, Madrid, 28007
Hospital San Carlos
Madrid, Madrid, 28040
Hospital Puerta del Hierro
Majadahonda, Madrid, 28222
Corporación Sanitaria Parc Taulí
Sabadell, Barcelona, 08208
Hospital Marqués de Valdecilla
Santander, Cantabria, 39011
About this study
Official title: Test of Efficacy and Safety of the Dual Antiplatelet Therapy Compared to the Combination of Oral Anticoagulant Therapy + Dual Antiplatelet Therapy in Patients With Atrial Fibrillation With Low-moderate Risk Submitted to Coronary Stent Implantation
Objective:
The main objective is to evaluate the pattern of dual antiplatelet therapy (aspirin, 300 mg / day + clopidogrel 75 mg / day) compared to the use of the triple regimen (Acenocoumarol as control + acetylsalicylic acid 100 mg / day + Clopidogrel 75 mg / day) in patients with atrial fibrillation, low-moderate risk of stroke (CHADS ≤ 2) who are undergoing PCI-S.
Design:
Randomized, parallel, with two arms, blind evaluation by third parties.
Patients:
304 patients undergoing PCI-S with atrial fibrillation, low-moderate risk of stroke (CHADS ≤ 2), which requires prevention of thrombosis
- Conditions
- Atrial Fibrillation, Stroke
- Being tested
- Acetylsalicylic Acid + clopidogrel + acenocoumarol, Acetylsalicylic Acid + clopidogrel
- Keywords
- atrial fibrillation, Coronary Stent implantation, Low-moderate risk of stroke, dual antiplatelet therapy, anticoagulation
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic Acid + clopidogrel + acenocoumarolDrug
Acetylsalicylic Acid 100 mg daily + Clopidogrel 75 mg daily + Acenocoumarol dosage with INR monitoring
Treatment : 6 weeks for bare metal stent and 12 months for drug elution stent
Acetylsalicylic Acid + clopidogrelDrug
Salicylic Acid, 300 mg daily + Clopidogrel 75 mg daily
Treatment : 6 weeks for bare metal stent and 12 months for drug elution stent.
| Study group | Role | What they receive |
|---|---|---|
| Oral anticoagulation plus dual antiplatelet therapy | Experimental | Not described Receives: Drug: Acetylsalicylic Acid + clopidogrel + acenocoumarol |
| Dual antiplatelet therapy | Active comparator | Not described Receives: Drug: Acetylsalicylic Acid + clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death
Incidence of the composite major events (stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death) until 12 months after the initial treatment
Measured: until 12 months
Secondary outcomes (2)
Incidence of major and minor bleeding
Measured: until 12 months
Adverse events
Measured: until 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
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 Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonia Sambola, MD Ph, Principal investigatorDavid García -Dorado, MD Ph, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141153
- Sponsor's protocol ID
- MUSICA-2
- Other IDs
- 2009-017256-27, 2009
- Acronym
- MUSICA-2
- Status last verified
- Feb 2015
- First submitted
- 9 Jun 2010
- Last updated
- 24 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sambola A, Montoro JB, Del Blanco BG, Llavero N, Barrabes JA, Alfonso F, Bueno H, Cequier A, Serra A, Zueco J, Sabate M, Rodriguez-Leor O, Garcia-Dorado D. Dual antiplatelet therapy versus oral anticoagulation plus dual antiplatelet therapy in patients with atrial fibrillation and low-to-moderate thromboembolic risk undergoing coronary stenting: design of the MUSICA-2 randomized trial. Am Heart J. 2013 Oct;166(4):669-75. doi: 10.1016/j.ahj.2013.07.028. Epub 2013 Sep 14.
PubMed 24093846
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test of Efficacy and Safety of the Dual Antiplatelet Therapy Compared to the Combination of Oral Anticoagulant Therapy + Dual Antiplatelet Therapy in Patients With Atrial Fibrillation With Low-moderate Risk Submitted to Coronary Stent Implantation
- ClinicalTrials.gov ID
- NCT01141153
- Acronym / sponsor ID
- MUSICA-2 / MUSICA-2
- Conditions
- Atrial Fibrillation, Stroke
- Keywords
- atrial fibrillation, Coronary Stent implantation, Low-moderate risk of stroke, dual antiplatelet therapy, anticoagulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 10 Jun 2010 (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.
Objective:
The main objective is to evaluate the pattern of dual antiplatelet therapy (aspirin, 300 mg / day + clopidogrel 75 mg / day) compared to the use of the triple regimen (Acenocoumarol as control + acetylsalicylic acid 100 mg / day + Clopidogrel 75 mg / day) in patients with atrial fibrillation, low-moderate risk of stroke (CHADS ≤ 2) who are undergoing PCI-S.
Design:
Randomized, parallel, with two arms, blind evaluation by third parties.
Patients:
304 patients undergoing PCI-S with atrial fibrillation, low-moderate risk of stroke (CHADS ≤ 2), which requires prevention of thrombosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral anticoagulation plus dual antiplatelet therapy | Experimental | Drug: Acetylsalicylic Acid + clopidogrel + acenocoumarol |
| Dual antiplatelet therapy | Active comparator | Drug: Acetylsalicylic Acid + clopidogrel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of both sexes older than 18 years.
- Patients with permanent atrial fibrillation, persistent or paroxysmal (at least one episode), documented electrocardiographically and receiving oral anticoagulation. Patients with acute coronary syndrome or stable angina who are undergoing PCI-S.
- Patients who have previously given their informed consent to participation in the study.
Key exclusion criteria (11 listed)
- Patients who can not be followed by the research team during the 12 months provided for monitoring.
- Patients with renal failure or serum creatinine above 2 mg • dL-1, neurological deficits, active ulcer or epigastric pain.
- Patients who continue regular treatment with NSAIDs or other analgesics or corticosteroids.
- Patients undergoing reoperation.
- Patients who during the study period, should receive, according to medical criteria, other adjuvant drug treatment than that specified in this protocol.
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 |
|---|---|---|
| Acetylsalicylic Acid + clopidogrel + acenocoumarolAcetylsalicylic Acid 100 mg daily + Clopidogrel 75 mg daily + Acenocoumarol dosage with INR monitoring Treatment : 6 weeks for bare metal stent and 12 months for drug elution stent | Drug | Oral anticoagulation plus dual antiplatelet therapy |
| Acetylsalicylic Acid + clopidogrelSalicylic Acid, 300 mg daily + Clopidogrel 75 mg daily Treatment : 6 weeks for bare metal stent and 12 months for drug elution stent. | Drug | Dual antiplatelet therapy |
Primary outcome
A composite of stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death
Time frame: until 12 months
Incidence of the composite major events (stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death) until 12 months after the initial treatment
2 secondary outcomes
Incidence of major and minor bleeding
Time frame: until 12 months
Adverse events
Time frame: until 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2015.
- Derived from this study: PubMed 24093846Sambola A, Montoro JB, Del Blanco BG, Llavero N, Barrabes JA, Alfonso F, Bueno H, Cequier A, Serra A, Zueco J, Sabate M, Rodriguez-Leor O, Garcia-Dorado D. Dual antiplatelet therapy versus oral anticoagulation plus dual antiplatelet therapy in patients with atrial fibrillation and low-to-moderate thromboembolic risk undergoing coronary stenting: design of the MUSICA-2 randomized trial. Am Heart J. 2013 Oct;166(4):669-75. doi: 10.1016/j.ahj.2013.07.028. Epub 2013 Sep 14.
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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.
Antonia Sambola, MD Ph principal investigator
David García -Dorado, MD Ph study director
11 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 Acetylsalicylic Acid + clopidogrel + acenocoumarol and Acetylsalicylic Acid + clopidogrel in people with Atrial Fibrillation and Stroke, run by Hospital Universitari Vall d'Hebron Research Institute at 11 sites in Spain.
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 11 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 24 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain. 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?
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?
A composite of stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death (time frame: until 12 months). 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 NCT01141153, 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 24 Feb 2015.