Spontaneous Coronary Artery DissectionPhase 4BA-SCADNCT04850417
Randomized Study of Beta-Blockers and Antiplatelets in Patients With Spontaneous Coronary Artery Dissection
A Phase 4 study testing Beta blocker, aspirin, clopidogrel in people with Spontaneous Coronary Artery Dissection, run by Spanish Society of Cardiology.
Trial summary
Spontaneous coronary artery dissection (SCAD) is a cause of acute coronary syndrome (ACS). Most patients are treated with beta-blockers (BB) and antiplatelet drugs (AP) on empiric basis. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Spontaneous Coronary Artery Dissection
- What is being tested?
- Beta blocker, aspirin, clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2021to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Angiographic diagnosis of SCAD
- Admission for ACS or other manifestations of ischemia
- Informed consent
Who cannot join
- Cardiogenic shock or severe hemoynamic instability
- Concomitant severe heart disease requiring surgical correction (in <2 years)
- Medical condition seriously limiting life expectancy (< 2 years)
- Allergies or contraindication to drugs required in one of the study arms; the patient may be randomized in the other arm (factorial design)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Spanish Society of Cardiology Spanish Society of Cardiology contact
About this study
Official title: Randomized Clinical Trial Assessing the Value of Beta-Blockers and Antiplatelet Agents in Patients With Spontaneous Coronary Artery Dissection. (The BA-SCAD Randomized Clinical Trial)
Spontaneous coronary artery dissection (SCAD) is a cause of acute coronary syndrome (ACS). Most patients are treated with beta-blockers (BB) and antiplatelet drugs (AP) on empiric basis. The Beta-Blockers and Antiplatelet Agents in Patients with Spontaneous Coronary Artery Dissection (BA-SCAD) randomized clinical trial is an academic, pragmatic, nation-wide, prospective study developed under the auspices of the Spanish Society of Cardiology (SEC) that aims to assess the efficacy of medical therapy in SCAD patients. Using a factorial 2x2 design, patients will be randomized (1:1/1:1) to: 1) BB (yes/no) and 2) short AP regimen (1 month) vs prolonged dual AP therapy (DAPT) (12 months).Only patients with preserved left ventricular ejection fraction (LVEF) will be randomized to BB (yes/no) because patients with LVEF <40% will receive BB according to current guidelines. Likewise, only medically managed patients will be randomized to short AP therapy vs 1-year DAPT. The study will have a pragmatic, open label, blind outcomes design (PROBE). A total of 600 SCAD patients will be randomized within 2 years (300 per arm in a factorial 2x2 design). The primary efficacy endpoint will include the composite of death, acute myocardial infarction (MI), stroke, coronary revascularization, recurrent SCAD, and unplanned hospitalization for ACS or heart failure at 1 year. The primary safety endpoint will be bleeding. All patients will be clinically followed yearly. The main study will be pragmatic but a comprehensive set of additional studies (clinical, imaging, biomarkers, inflammatory, immunologic, pharmacogenetic and genetic) will be organized to ensure an holistic view on this challenging condition.
Read the detailed description
Spontaneous coronary artery dissection (SCAD) is a relatively rare but important and increasingly recognized cause of acute coronary syndrome (ACS). Most patients presenting with SCAD are treated with beta-blockers (BB) and antiplatelet drugs (AP). Although appealing from a pathophysiological standpoint, such management strategy is completely empiric. The Beta-Blockers and Antiplatelet Agents in Patients with Spontaneous Coronary Artery Dissection (BA-SCAD) randomized clinical trial is an academic, pragmatic, nation-wide, prospective study developed under the auspices of the Spanish Society of Cardiology (SEC) that aims to assess the efficacy of medical therapy in SCAD patients. Using a factorial 2x2 design, patients will be randomized (1:1/1:1) to: 1) BB (yes/no) and 2) short AP regimen (1 month) vs prolonged dual AP therapy (DAPT) (12 months). A conservative medical management will be initially recommended, with coronary revascularization reserved for patients with ongoing/refractory ischemia. Only patients with preserved left ventricular ejection fraction (LVEF) will be randomized to BB (yes/no) because patients with LVEF <40% will receive BB according to current guidelines. Likewise, only medically managed patients will be randomized to short AP therapy vs 1-year DAPT, because patients requiring coronary interventions will receive DAPT. The study will have a pragmatic, open label, blind outcomes design (PROBE). The type and dose of BB and AP agents will be at the discretion of the treating physician. Treatment adherence will be reinforced and closely monitored and the potential influence of drug discontinuation/cross-over on outcomes will be carefully evaluated. A total of 600 SCAD patients will be randomized within 2 years (300 per arm in a factorial 2x2 design). The primary efficacy endpoint will include the composite of death, acute myocardial infarction (MI), stroke, coronary revascularization, recurrent SCAD, and unplanned hospital admission for ACS or heart failure at 1 year. The primary safety endpoint will be bleeding according the Bleeding Academic Research Consortium (BARC) criteria ≥ 3. An analysis of net clinical benefit, including primary efficacy and safety endpoints, will also be performed. All patients will be clinically followed at 1 year (primary endpoint) and yearly thereafter. Although the main study will be pragmatic, following routine clinical practice, a systematic and comprehensive set of additional ancillary studies and investigations (clinical, imaging, biomarkers, inflammatory, immunologic, pharmacogenetic and genetic) will be prospectively organized to ensure a multidisciplinary and holistic view on this challenging condition.
- Conditions
- Spontaneous Coronary Artery Dissection
- Being tested
- Beta blocker, aspirin, clopidogrel
- Keywords
- Spontaneous coronary artery dissection, Beta-blockers, Antiplatelets, Coronary angiography, Intracoronary imaging, Biomarkers, Myocardial infarction
- Medical subject headings
- Coronary Artery Dissection, Spontaneous, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta blocker, aspirin, clopidogrelDrug
Also called Beta-blockers, Aspirin, Clopidogrel
Pragmatic design. Beta-blockers and Antiplatelets drugs selected by the investigators. Asprin and Clopidogrel recomended for patients allocated to prologed DAPT. Aspirin Alone recomended for patients allocated to short antiplatelet therapy
| Study group | Role | What they receive |
|---|---|---|
| Beta-blockers and Short Antiplatelet Therapy | Experimental | Beta-blockers (experimental) and Short Antiplatelet Therapy (experimental). Aspirin alone recommended for Short Antiplatelet Therapy
(The main comparison of this randomized clinical trial (2x2, factorial design) is beta-blockers vs no beta-blockers and short vs long-term antiplatelet therapy) Receives: Drug: Beta blocker, aspirin, clopidogrel |
| Beta-blockers and Long Antiplatelet Therapy | Experimental | Beta-blockers (experimental) and Long Antiplatelet Therapy. Aspirin and Clopidogrel recommended in Long Antiplatelet Therapy
(The main comparison of this randomized clinical trial (2x2, factorial design) is beta-blockers vs no beta-blockers and short vs long-term antiplatelet therapy) Receives: Drug: Beta blocker, aspirin, clopidogrel |
| No Beta-blockers and Short Antiplatelet Therapy | Experimental | No Beta-blockers and Short Antiplatelet Therapy (experimental). Aspirin alone recommended in Short Antiplatelet Therapy
(The main comparison of this randomized clinical trial (2x2, factorial design) is beta-blockers vs no beta-blockers and short vs long-term antiplatelet therapy) Receives: Drug: Beta blocker, aspirin, clopidogrel |
| No Beta-blockers and Long Antiplatelet Therapy | Active comparator | No Beta-blockers and Long Antiplatelet Therapy. Aspirin and Clopidogrel recommended in Long Antiplatelet Therapy
(The main comparison of this randomized clinical trial (2x2, factorial design) is beta-blockers vs no beta-blockers and short vs long-term antiplatelet therapy) Receives: Drug: Beta blocker, aspirin, clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE (death, myocardial infarction, coronary revascularization, recurrent SCAD, stroke, unplanned admission for heart failure or acute coronary syndrome with dynamic ECG changes)
MACE (death, myocardial infarction, coronary revascularization, recurrent SCAD, stroke, unplanned admission for heart failure or acute coronary syndrome with dynamic ECG changes)
Measured: 1 year
Secondary outcomes (14)
MACE (death, myocardial infarction, coronary revascularization, stroke and heart failure)
MACE (death, myocardial infarction, coronary revascularization, stroke and heart failure)
Measured: 1, 2 and 3 years
MACE (death, myocardial infarction, coronary revascularization)
MACE (death, myocardial infarction, coronary revascularization)
Measured: 1, 2 and 3 years
MACE (death, myocardial infarction)
MACE (death, myocardial infarction)
Measured: 1, 2 and 3 years
MACE (death, myocardial infarction, coronary revascularization, recurrent SCAD, stroke, unplanned admission for heart failure or acute coronary syndrome with dynamic ECG changes)
MACE (death, myocardial infarction, coronary revascularization, recurrent SCAD, stroke, unplanned admission for heart failure or acute coronary syndrome with dynamic ECG changes)
Measured: 2, 3,4 and 5 years
Safety: Major Bleeding
Major Bleeding (BARC >=3)
Measured: 1 year
Safety: Bleeding
Bleeding (BARC >=2)
Measured: 1 year
MACE and Bleeding
MACE (death, myocardial infarction, coronary revascularization, recurrent SCAD, stroke, unplanned admission for heart failure or acute coronary syndrome with dynamic ECG changes) and bleeding
Measured: 1, 2 and 3 years
Death
Death
Measured: 1, 2 and 3 years
Myocardial infarction
Myocardial infarction
Measured: 1, 2 and 3 years
Coronary revascularization
Coronary revascularization
Measured: 1, 2 and 3 years
Recurrent SCAD
Recurrent SCAD
Measured: 1, 2 and 3 years
Stroke
Stroke
Measured: 1, 2 and 3 years
Unplanned admission for heart failure
Unplanned admission for heart failure
Measured: 1, 2 and 3 years
Unplanned admission for acute coronary syndrome with dynamic ECG changes
Unplanned admission for acute coronary syndrome with dynamic ECG changes
Measured: 1, 2, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start30 Apr 2021 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2028 (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 Spontaneous Coronary Artery DissectionStudies 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
- Factorial
- Model description
- Factorial 2x2 design (a) beta-blockers yes/no; b) Antiplatelets short/long)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spanish Society of Cardiology
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigación Sanitaria Hospital Universitario de la Princesa, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Responsible party
- Principal investigator, Fernando Alfonso, Spanish Society of Cardiology
- Investigators
- Spanish Society of Cardiology Spanish Society of Cardiology, Study chair, Spanish Society of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850417
- Sponsor's protocol ID
- BA-SCAD
- Acronym
- BA-SCAD
- Status last verified
- Apr 2021
- First submitted
- 7 Apr 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To be decided by the steering committee upon formal official request by academic investigators
Publications
Alfonso F, de la Torre Hernandez JM, Ibanez B, Sabate M, Pan M, Gulati R, Saw J, Angiolillo DJ, Adlam D, Sanchez-Madrid F. Rationale and design of the BA-SCAD (Beta-blockers and Antiplatelet agents in patients with Spontaneous Coronary Artery Dissection) randomized clinical trial. Rev Esp Cardiol (Engl Ed). 2022 Jun;75(6):515-522. doi: 10.1016/j.rec.2021.08.003. Epub 2021 Sep 22. English, Spanish.
PubMed 34561195
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Assessing the Value of Beta-Blockers and Antiplatelet Agents in Patients With Spontaneous Coronary Artery Dissection. (The BA-SCAD Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04850417
- Acronym / sponsor ID
- BA-SCAD / BA-SCAD
- Conditions
- Spontaneous Coronary Artery Dissection
- Keywords
- Spontaneous coronary artery dissection, Beta-blockers, Antiplatelets, Coronary angiography, Intracoronary imaging, Biomarkers, Myocardial infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Spanish Society of CardiologyUniversity, hospital or other
- Collaborators
- Instituto de Investigación Sanitaria Hospital Universitario de la Princesa, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Study start
- 30 Apr 2021 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Apr 2021 (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.
Spontaneous coronary artery dissection (SCAD) is a cause of acute coronary syndrome (ACS). Most patients are treated with beta-blockers (BB) and antiplatelet drugs (AP) on empiric basis. The Beta-Blockers and Antiplatelet Agents in Patients with Spontaneous Coronary Artery Dissection (BA-SCAD) randomized clinical trial is an academic, pragmatic, nation-wide, prospective study developed under the auspices of the Spanish Society of Cardiology (SEC) that aims to assess the efficacy of medical therapy in SCAD patients. Using a factorial 2x2 design, patients will be randomized (1:1/1:1) to: 1) BB (yes/no) and 2) short AP regimen (1 month) vs prolonged dual AP therapy (DAPT) (12 months).Only patients with preserved left ventricular ejection fraction (LVEF) will be randomized to BB (yes/no) because patients with LVEF <40% will receive BB according to current guidelines. Likewise, only medically managed patients will be randomized to short AP therapy vs 1-year DAPT. The study will have a pragmatic, open label, blind outcomes design (PROBE). A total of 600 SCAD patients will be randomized within 2 years (300 per arm in a factorial 2x2 design). The primary efficacy endpoint will include the composite of death, acute myocardial infarction (MI), stroke, coronary revascularization, recurrent SCAD, and unplanned hospitalization for ACS or heart failure at 1 year. The primary safety endpoint will be bleeding. All patients will be clinically followed yearly. The main study will be pragmatic but a comprehensive set of additional studies (clinical, imaging, biomarkers, inflammatory, immunologic, pharmacogenetic and genetic) will be organized to ensure an holistic view on this challenging condition.
Detailed description
Spontaneous coronary artery dissection (SCAD) is a relatively rare but important and increasingly recognized cause of acute coronary syndrome (ACS). Most patients presenting with SCAD are treated with beta-blockers (BB) and antiplatelet drugs (AP). Although appealing from a pathophysiological standpoint, such management strategy is completely empiric. The Beta-Blockers and Antiplatelet Agents in Patients with Spontaneous Coronary Artery Dissection (BA-SCAD) randomized clinical trial is an academic, pragmatic, nation-wide, prospective study developed under the auspices of the Spanish Society of Cardiology (SEC) that aims to assess the efficacy of medical therapy in SCAD patients. Using a factorial 2x2 design, patients will be randomized (1:1/1:1) to: 1) BB (yes/no) and 2) short AP regimen (1 month) vs prolonged dual AP therapy (DAPT) (12 months). A conservative medical management will be initially recommended, with coronary revascularization reserved for patients with ongoing/refractory ischemia. Only patients with preserved left ventricular ejection fraction (LVEF) will be randomized to BB (yes/no) because patients with LVEF <40% will receive BB according to current guidelines. Likewise, only medically managed patients will be randomized to short AP therapy vs 1-year DAPT, because patients requiring coronary interventions will receive DAPT. The study will have a pragmatic, open label, blind outcomes design (PROBE). The type and dose of BB and AP agents will be at the discretion of the treating physician. Treatment adherence will be reinforced and closely monitored and the potential influence of drug discontinuation/cross-over on outcomes will be carefully evaluated. A total of 600 SCAD patients will be randomized within 2 years (300 per arm in a factorial 2x2 design). The primary efficacy endpoint will include the composite of death, acute myocardial infarction (MI), stroke, coronary revascularization, recurrent SCAD, and unplanned hospital admission for ACS or heart failure at 1 year. The primary safety endpoint will be bleeding according the Bleeding Academic Research Consortium (BARC) criteria ≥ 3. An analysis of net clinical benefit, including primary efficacy and safety endpoints, will also be performed. All patients will be clinically followed at 1 year (primary endpoint) and yearly thereafter. Although the main study will be pragmatic, following routine clinical practice, a systematic and comprehensive set of additional ancillary studies and investigations (clinical, imaging, biomarkers, inflammatory, immunologic, pharmacogenetic and genetic) will be prospectively organized to ensure a multidisciplinary and holistic view on this challenging condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Factorial 2x2 design (a) beta-blockers yes/no; b) Antiplatelets short/long)
| Arm | Type | Receives |
|---|---|---|
| Beta-blockers and Short Antiplatelet Therapy | Experimental | Drug: Beta blocker, aspirin, clopidogrelBeta-blockers (experimental) and Short Antiplatelet Therapy (experimental). Aspirin alone recommended for Short Antiplatelet Therapy (The main comparison of this randomized clinical trial (2x2, factorial design) is beta-blockers vs no beta-blockers and short vs long-term antiplatelet therapy) |
| Beta-blockers and Long Antiplatelet Therapy | Experimental | Drug: Beta blocker, aspirin, clopidogrelBeta-blockers (experimental) and Long Antiplatelet Therapy. Aspirin and Clopidogrel recommended in Long Antiplatelet Therapy (The main comparison of this randomized clinical trial (2x2, factorial design) is beta-blockers vs no beta-blockers and short vs long-term antiplatelet therapy) |
| No Beta-blockers and Short Antiplatelet Therapy | Experimental | Drug: Beta blocker, aspirin, clopidogrelNo Beta-blockers and Short Antiplatelet Therapy (experimental). Aspirin alone recommended in Short Antiplatelet Therapy (The main comparison of this randomized clinical trial (2x2, factorial design) is beta-blockers vs no beta-blockers and short vs long-term antiplatelet therapy) |
| No Beta-blockers and Long Antiplatelet Therapy | Active comparator | Drug: Beta blocker, aspirin, clopidogrelNo Beta-blockers and Long Antiplatelet Therapy. Aspirin and Clopidogrel recommended in Long Antiplatelet Therapy (The main comparison of this randomized clinical trial (2x2, factorial design) is beta-blockers vs no beta-blockers and short vs long-term antiplatelet therapy) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Angiographic diagnosis of SCAD
- Admission for ACS or other manifestations of ischemia
- Informed consent
Key exclusion criteria (4 listed)
- Cardiogenic shock or severe hemoynamic instability
- Concomitant severe heart disease requiring surgical correction (in <2 years)
- Medical condition seriously limiting life expectancy (< 2 years)
- Allergies or contraindication to drugs required in one of the study arms; the patient may be randomized in the other arm (factorial design)
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 |
|---|---|---|
| Beta blocker, aspirin, clopidogrelAlso: Beta-blockers, Aspirin, ClopidogrelPragmatic design. Beta-blockers and Antiplatelets drugs selected by the investigators. Asprin and Clopidogrel recomended for patients allocated to prologed DAPT. Aspirin Alone recomended for patients allocated to short antiplatelet therapy | Drug | Beta-blockers and Long Antiplatelet Therapy, Beta-blockers and Short Antiplatelet Therapy, No Beta-blockers and Long Antiplatelet Therapy, No Beta-blockers and Short Antiplatelet Therapy |
Primary outcome
MACE (death, myocardial infarction, coronary revascularization, recurrent SCAD, stroke, unplanned admission for heart failure or acute coronary syndrome with dynamic ECG changes)
Time frame: 1 year
MACE (death, myocardial infarction, coronary revascularization, recurrent SCAD, stroke, unplanned admission for heart failure or acute coronary syndrome with dynamic ECG changes)
14 secondary outcomes
MACE (death, myocardial infarction, coronary revascularization, stroke and heart failure)
Time frame: 1, 2 and 3 years
MACE (death, myocardial infarction, coronary revascularization)
Time frame: 1, 2 and 3 years
MACE (death, myocardial infarction)
Time frame: 1, 2 and 3 years
MACE (death, myocardial infarction, coronary revascularization, recurrent SCAD, stroke, unplanned admission for heart failure or acute coronary syndrome with dynamic ECG changes)
Time frame: 2, 3,4 and 5 years
Safety: Major Bleeding
Time frame: 1 year
Safety: Bleeding
Time frame: 1 year
MACE and Bleeding
Time frame: 1, 2 and 3 years
Death
Time frame: 1, 2 and 3 years
Myocardial infarction
Time frame: 1, 2 and 3 years
Coronary revascularization
Time frame: 1, 2 and 3 years
Recurrent SCAD
Time frame: 1, 2 and 3 years
Stroke
Time frame: 1, 2 and 3 years
Unplanned admission for heart failure
Time frame: 1, 2 and 3 years
Unplanned admission for acute coronary syndrome with dynamic ECG changes
Time frame: 1, 2, 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Derived from this study: PubMed 34561195Alfonso F, de la Torre Hernandez JM, Ibanez B, Sabate M, Pan M, Gulati R, Saw J, Angiolillo DJ, Adlam D, Sanchez-Madrid F. Rationale and design of the BA-SCAD (Beta-blockers and Antiplatelet agents in patients with Spontaneous Coronary Artery Dissection) randomized clinical trial. Rev Esp Cardiol (Engl Ed). 2022 Jun;75(6):515-522. doi: 10.1016/j.rec.2021.08.003. Epub 2021 Sep 22. English, Spanish.
- Individual participant dataSharing planned: Yes. To be decided by the steering committee upon formal official request by academic investigators
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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.
Spanish Society of Cardiology Spanish Society of Cardiology contact
Spanish Society of Cardiology Spanish Society of Cardiology study chair
Spanish Society of Cardiology
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Beta blocker, aspirin, clopidogrel in people with Spontaneous Coronary Artery Dissection, run by Spanish Society of Cardiology.
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 4 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: opening soon, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fernando Alfonso, MD (34 680483165, falf@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (death, myocardial infarction, coronary revascularization, recurrent SCAD, stroke, unplanned admission for heart failure or acute coronary syndrome with dynamic ECG changes) (time frame: 1 year). 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 NCT04850417, 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 20 Apr 2021.