Randomized clinical trial assessing the value of Beta-Blockers and Antiplatelet Agents in patients with Spontaneous Coronary Artery Dissection (BA-SCAD).

Conditions

Spontaneous Coronary Artery Dissection.

Brief summary

A combined clinical endpoint including death, MI, stroke, coronary revascularization, recurrent dissection and hospital admission for ACS or heart failure at 1-year follow-up.

Detailed description

a secondary combined clinical endpoint (composite of death, MI, stroke, coronary revascularization, and recurrent dissection, hospital admission for ACS –with dynamic ECG changes- or heart failure or bleeding) will be used to assess the “net clinical benefit” of the antiplatelet strategy., Bleeding will be also analyzed as a separate safety secondary endpoint. Bleeding will be defined according to BARC definitions., Individual components of the primary endpoint will be assessed as secondary endpoints. Besides, a major predefined secondary combined endpoint will be the composite outcome measure of “hard” clinical events (including death, MI, stroke, recurrent dissection and coronary revascularization) and the combined outcome measure of death and MI alone.

Related papers

No related papers found yet.

Interventions

DRUGACETYLSALICYLIC ACID

DRUGPRASUGREL

DRUGMETOPROLOL

DRUGPROPRANOLOL

DRUGATENOLOL

DRUGCARVEDILOL

DRUGCLOPIDOGREL

DRUGBISOPROLOL

DRUGTICAGRELOR

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
A combined clinical endpoint including death, MI, stroke, coronary revascularization, recurrent dissection and hospital admission for ACS or heart failure at 1-year follow-up.	—

Secondary

Measure	Time frame
a secondary combined clinical endpoint (composite of death, MI, stroke, coronary revascularization, and recurrent dissection, hospital admission for ACS –with dynamic ECG changes- or heart failure or bleeding) will be used to assess the “net clinical benefit” of the antiplatelet strategy., Bleeding will be also analyzed as a separate safety secondary endpoint. Bleeding will be defined according to BARC definitions., Individual components of the primary endpoint will be assessed as secondary endpoints. Besides, a major predefined secondary combined endpoint will be the composite outcome measure of “hard” clinical events (including death, MI, stroke, recurrent dissection and coronary revascularization) and the combined outcome measure of death and MI alone.	—

Measure

Time frame

a secondary combined clinical endpoint (composite of death, MI, stroke, coronary revascularization, and recurrent dissection, hospital admission for ACS –with dynamic ECG changes- or heart failure or bleeding) will be used to assess the “net clinical benefit” of the antiplatelet strategy., Bleeding will be also analyzed as a separate safety secondary endpoint. Bleeding will be defined according to BARC definitions., Individual components of the primary endpoint will be assessed as secondary endpoints. Besides, a major predefined secondary combined endpoint will be the composite outcome measure of “hard” clinical events (including death, MI, stroke, recurrent dissection and coronary revascularization) and the combined outcome measure of death and MI alone.

—

Countries

Spain

Outcome results

None listed