COLchicine in BElgium in patients with coronary artery disease after Percutaneous Coronary Intervention

Conditions

Coronary artery disease

Brief summary

The primary endpoint is time from randomisation to first occurrence of a composite endpoint consisting of: all-cause death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B & C), non-fatal stroke, or coronary revascularisation.

Detailed description

Time from randomisation to first occurrence of: ▪ a composite of specific cardiovascular endpoint consisting of: cardiovascular death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B & C), non-fatal stroke or coronary revascularisation ▪ a composite of hard endpoints consisting of: all-cause death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B & C), non-fatal stroke ▪ Breakdown components of primary endpoint and atherosclerosis-related diseases, Time from randomisation to occurrence of first as well as recurrent endpoints consisting of: all-cause death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B & C), non-fatal stroke, or coronary revascularisation., Change from randomisation to year 1 and to end of study of participants reported outcomes (based on ICHOM Standard Set for CAD) o Seattle Angina Questionnaire (SAQ) Angina Frequency Scale o Dyspnea (Rose Dyspnea Scale) o Depression (Patient Health Questionnaire PHQ-2)

Related papers

No related papers found yet.

Interventions

DRUGColchicine Tiofarma 500 microgram Tablets

DRUGPlacebo Colchicine 0.5 mg tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is time from randomisation to first occurrence of a composite endpoint consisting of: all-cause death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B & C), non-fatal stroke, or coronary revascularisation.	—

Secondary

Measure	Time frame
Time from randomisation to first occurrence of: ▪ a composite of specific cardiovascular endpoint consisting of: cardiovascular death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B & C), non-fatal stroke or coronary revascularisation ▪ a composite of hard endpoints consisting of: all-cause death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B & C), non-fatal stroke ▪ Breakdown components of primary endpoint and atherosclerosis-related diseases, Time from randomisation to occurrence of first as well as recurrent endpoints consisting of: all-cause death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B & C), non-fatal stroke, or coronary revascularisation., Change from randomisation to year 1 and to end of study of participants reported outcomes (based on ICHOM Standard Set for CAD) o Seattle Angina Questionnaire (SAQ) Angina Frequency Scale o Dyspnea (Rose Dyspnea Scale) o Depression (Patient Health Questionnai	—

Measure

Time frame

Time from randomisation to first occurrence of: ▪ a composite of specific cardiovascular endpoint consisting of: cardiovascular death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B & C), non-fatal stroke or coronary revascularisation ▪ a composite of hard endpoints consisting of: all-cause death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B & C), non-fatal stroke ▪ Breakdown components of primary endpoint and atherosclerosis-related diseases, Time from randomisation to occurrence of first as well as recurrent endpoints consisting of: all-cause death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B & C), non-fatal stroke, or coronary revascularisation., Change from randomisation to year 1 and to end of study of participants reported outcomes (based on ICHOM Standard Set for CAD) o Seattle Angina Questionnaire (SAQ) Angina Frequency Scale o Dyspnea (Rose Dyspnea Scale) o Depression (Patient Health Questionnai

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Countries

Belgium

Outcome results

None listed