[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100427777":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":37,"centralContacts":41,"locations":46,"responsibleParty":49,"collaborators":53,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":46,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":85,"whyStopped":46,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":46},{"fullName":5,"class":6},"Spanish Society of Cardiology","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Beta-blockers and Short Antiplatelet Therapy","EXPERIMENTAL","Beta-blockers (experimental) and Short Antiplatelet Therapy (experimental). Aspirin alone recommended for Short Antiplatelet Therapy\n\n(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)",[13],"Drug: Beta blocker, aspirin, clopidogrel",{"label":15,"type":10,"description":16,"interventionNames":17},"Beta-blockers and Long Antiplatelet Therapy","Beta-blockers (experimental) and Long Antiplatelet Therapy. Aspirin and Clopidogrel recommended in Long Antiplatelet Therapy\n\n(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)",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"No Beta-blockers and Short Antiplatelet Therapy","No Beta-blockers and Short Antiplatelet Therapy (experimental). Aspirin alone recommended in Short Antiplatelet Therapy\n\n(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)",[13],{"label":23,"type":24,"description":25,"interventionNames":26},"No Beta-blockers and Long Antiplatelet Therapy","ACTIVE_COMPARATOR","No Beta-blockers and Long Antiplatelet Therapy. Aspirin and Clopidogrel recommended in Long Antiplatelet Therapy\n\n(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)",[13],[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Beta blocker, 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",[15,9,23,19],[34,35,36],"Beta-blockers","Aspirin","Clopidogrel",[38],{"name":39,"affiliation":5,"role":40},"Spanish Society of Cardiology Spanish Society of Cardiology","STUDY_CHAIR",[42,48],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Fernando Alfonso, MD","CONTACT","34 680483165",null,"falf@hotmail.com",{"name":39,"role":44,"phone":46,"phoneExt":46,"email":46},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":46,"oldOrganization":46},"PRINCIPAL_INVESTIGATOR","Fernando Alfonso","Principal Investigator",[54,56],{"name":55,"class":6},"Instituto de Investigación Sanitaria Hospital Universitario de la Princesa",{"name":57,"class":6},"Fundación de Investigación Biomédica - Hospital Universitario de La Princesa","100427777","phase-4-randomized-study-of-beta-blockers-and-antiplatelets-in-patients-with-spontaneous-coronary-artery-dissection-100427777",false,"NCT04850417","Randomized Study of Beta-Blockers and Antiplatelets in Patients With Spontaneous Coronary Artery Dissection","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)","BA-SCAD","Inclusion Criteria:\n\n* Angiographic diagnosis of SCAD\n* Admission for ACS or other manifestations of ischemia\n* Informed consent\n\nExclusion Criteria:\n\n* Cardiogenic shock or severe hemoynamic instability\n* Concomitant severe heart disease requiring surgical correction (in \\\u003C2 years)\n* Medical condition seriously limiting life expectancy (\\\u003C 2 years)\n* Allergies or contraindication to drugs required in one of the study arms; the patient may be randomized in the other arm (factorial design)","ALL","18 Years","90 Years",{"count":70,"type":71},600,"ESTIMATED","INTERVENTIONAL",[74],"PHASE4","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\u002F1:1) to: 1) BB (yes\u002Fno) 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\u002Fno) because patients with LVEF \\\u003C40% 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.",[77],"Spontaneous Coronary Artery Dissection",[79,34,80,81,82,83,84],"Spontaneous coronary artery dissection","Antiplatelets","Coronary angiography","Intracoronary imaging","Biomarkers","Myocardial infarction","NOT_YET_RECRUITING","2021-04-14",{"date":88,"type":89},"2021-04-20","ACTUAL",{"date":91,"type":71},"2021-04-30",{"date":93,"type":71},"2028-12-31",{"name":5,"class":6}]