Colchicine for Acute Coronary Syndromes | NCT01906749

Studies
Colchicine for Acute Coronary Syndromes

NCT01906749

Sponsor

Maria Vittoria Hospital

Status

Unknown status

Last Update Posted

Jul 24, 2013Estimated

Enrollment

500Estimated

Phase

Phase 4

Conditions

Acute Coronary Syndrome

Interventions

Colchicine
Placebo

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2013-001415-78	EudraCT Number

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Jun 2016Estimated

Completion Date

Jun 2016Estimated

First Submitted Date

Jul 21, 2013

First Submission Date that Met QC Criteria

Jul 23, 2013

First Posted Date

Jul 24, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2013

Last Update Posted Date

Jul 24, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Multicenter, double blind, randomized trial to assess the effect of low-dose colchicine (0.5mg/day) on overall mortality, new coronary syndromes, and ischemic stroke at 2 years after an acute coronary syndrome. The study hypothesis is that colchicine may reduce the specified combined endpoint from 16% to 7-8% at a 2-years follow-up.

Detailed Description

Multicenter, double-blind randomized trial to evaluate the efficacy of low dose colchicine (0.5mg once daily for 2 years) to reduce the incidence of subsequent overall mortality, new acute coronary syndromes, and ischemic stroke in patients admitted for an acute coronary syndrome.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo	Drug: Placebo
Colchicine	Active Comparator	Colchicine 0.5mg once daily for 24 months	Drug: Colchicine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Colchicine	Drug	0.5mg once daily orally	Colchicine
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall mortality, new acute coronary syndrome, and ischemic stroke.		24 months

Secondary Outcomes

Measure	Description	Time Frame
Mortality	Secondary outcome measures will contain each issue of the combined primary endpoint as separate outcome.	24 months
New acute coronary syndrome (unstable angina and myocardial infarction)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>18years
Acute coronary syndrome (unstable angina or acute myocardial infarction)
Life expectancy> 2 years
Absence of contraindications to colchicine

Exclusion Criteria:

Colchicine treatment for any cause
Severe liver disease
Renal insufficiency with creatinine>150mmol/l or creatinine clearance<30ml/min/1.73m2
Known cancer
Chronic inflammatory bowel disease
treatment with cyclosporine
allergy or hypersensitivity to colchicine
pregnancy or lactating woman or woman with childbearing potential without valid contraception

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Massimo Imazio, MD	Contact	+39011439	3391	massimo_imazio@yahoo.it

Overall Officials

Name	Affiliation	Role
Massimo Imazio, MD	Cardiology Dpt.Maria Vittoria Hospital, Torino, Italy	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiology Dpt.	Not yet recruiting	Rivoli	Torino	10098	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32648087	Derived	Silvis MJM, Demkes EJ, Fiolet ATL, Dekker M, Bosch L, van Hout GPJ, Timmers L, de Kleijn DPV. Immunomodulation of the NLRP3 Inflammasome in Atherosclerosis, Coronary Artery Disease, and Acute Myocardial Infarction. J Cardiovasc Transl Res. 2021 Feb;14(1):23-34. doi: 10.1007/s12265-020-10049-w. Epub 2020 Jul 9.

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

ID	Term
D000470	Alkaloids
D006571	Heterocyclic Compounds