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Colchicine Protective Effect in Patients Undergoing Percutaneous Coronary Intervention (COLCHICINE-PROTECT)

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Colchicine 0.5 MG Oral Tablet
Placebo
Sponsored by
Helwan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Acute Coronary Syndrome, Percutaneous Coronary Intervention, Colchicine, Myocardial Injury, Inflammation, Myocardial Infarction, No Reflow

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Chronic Coronary Syndrome (CCS) participants referred for PCI. Acute Coronary Syndrome (ACS) participants who are medically treated or undergoing revascularization for non-culprit lesions will be included if their troponin I and hs-CRP returned back to normal baseline Exclusion Criteria: Acute Coronary Syndrome (ACS) participants. Chronic kidney disease (glomerular filltration rate <30 ml/ min). Participants with history of cirrhosis. Participants on systemic immunosuppressive or corticosteroid therapy. Active malignancy or infection. Elevated troponin I.

Sites / Locations

  • Helwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Colchicine

Placebo

Arm Description

0.5 mg colchicine tablets twice daily 72 to 48 hours before planned PCI

Matching placebo

Outcomes

Primary Outcome Measures

PCI related myocardial injury
Number of Participants with peak post-procedure Troponin I above the upper reference limit in participants with normal baseline cardiac biomarkers

Secondary Outcome Measures

PCI associated inflammation
Post PCI hs-CRP
No reflow phenomenon
Defined as Thrombolysis in Myocardial Infarction (TIMI) flow grade of less than 3.
PCI-related (type 4a) Myocardial Infarction (MI)
According to the 4th Universal Definition of MI

Full Information

First Posted
February 13, 2023
Last Updated
March 18, 2023
Sponsor
Helwan University
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1. Study Identification

Unique Protocol Identification Number
NCT05739929
Brief Title
Colchicine Protective Effect in Patients Undergoing Percutaneous Coronary Intervention (COLCHICINE-PROTECT)
Official Title
Colchicine Protective Effect in Patients Undergoing Elective Percutaneous Coronary Intervention (COLCHICINE-PROTECT) A Randomized, Placebo-controlled, Double-blind Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helwan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this clinical trial is to evaluate the colchicine protective effect in patients undergoing Percutaneous Coronary Intervention (PCI). The main question it aims to answer is: does initiating colchicine before planned PCI will reduce post-procedural myocardial injury? Half of the participants will receive colchicine, while the other half will receive a placebo.
Detailed Description
Inflammation in the setting of PCI is associated with endothelial dysfunction and microvascular obstruction and remains an independent predictor of subsequent major adverse cardiovascular events (MACE) even in the contemporary era of second-generation drug-eluting stents (DES). Inflammation also increases the risk of PCI-related myocardial injury, which is associated with long-term all-cause mortality. Colchicine is an inexpensive, orally administered, potent anti-inflammatory medication. Recent major trials showed that using low-dose colchicine on top of GDMT reduces cardiovascular events in patients with either chronic coronary syndrome (CCS) or acute Myocardial infarction (MI). A recent meta-analysis showed that using colchicine in the setting of PCI also reduces cardiovascular events, however, the optimal regimen to subside PCI-associated inflammation is still not clear. Our aims are Evaluation of colchicine efficacy in protecting against PCI myocardial injury. Our hypothesis is that initiating colchicine 0.5 mg twice daily 72 to 48 hours before planned PCI in CCS patients will decrease PCI-related myocardial injury. Evaluation of colchicine efficacy in preventing PCI-associated inflammation. Our hypothesis is that colchicine will subside post-PCI rise in high sensitive C-Reactive-Protein (hs-CRP). Evaluation of colchicine efficacy in preventing no-reflow phenomenon. Our hypothesis is that colchicine will decrease no reflow phenomenon in CCS patients undergoing PCI. Evaluation of colchicine efficacy in preventing PCI-related (type 4a) MI per the 4th Universal Definition. Our hypothesis is that colchicine will decrease PCI-related (type 4a) MI in CCS patients undergoing PCI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease, Acute Coronary Syndrome, Percutaneous Coronary Intervention, Colchicine, Myocardial Injury, Inflammation, Myocardial Infarction, No Reflow

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Colchicine
Arm Type
Active Comparator
Arm Description
0.5 mg colchicine tablets twice daily 72 to 48 hours before planned PCI
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
Colchicine 0.5 MG Oral Tablet
Other Intervention Name(s)
Colcrys, Gloperba, Mitigare
Intervention Description
0.5 mg colchicine tablets twice daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets twice daily
Primary Outcome Measure Information:
Title
PCI related myocardial injury
Description
Number of Participants with peak post-procedure Troponin I above the upper reference limit in participants with normal baseline cardiac biomarkers
Time Frame
6 hours after PCI
Secondary Outcome Measure Information:
Title
PCI associated inflammation
Description
Post PCI hs-CRP
Time Frame
6 hours after PCI
Title
No reflow phenomenon
Description
Defined as Thrombolysis in Myocardial Infarction (TIMI) flow grade of less than 3.
Time Frame
During the PCI procedure
Title
PCI-related (type 4a) Myocardial Infarction (MI)
Description
According to the 4th Universal Definition of MI
Time Frame
6 hours after PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic Coronary Syndrome (CCS) participants referred for PCI. Acute Coronary Syndrome (ACS) participants who are medically treated or undergoing revascularization for non-culprit lesions will be included if their troponin I and hs-CRP returned back to normal baseline Exclusion Criteria: Acute Coronary Syndrome (ACS) participants. Chronic kidney disease (glomerular filltration rate <30 ml/ min). Participants with history of cirrhosis. Participants on systemic immunosuppressive or corticosteroid therapy. Active malignancy or infection. Elevated troponin I.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed A Ammar, MD, MSc
Phone
+201000089300
Email
mohammed.ahmed5@med.helwan.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed A Ammar, MD, MSc
Organizational Affiliation
Helwan University, Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helwan University Hospital
City
Helwan
State/Province
Cairo
ZIP/Postal Code
11795
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed A Ammar, MD, MSc
Phone
+201000089300
Email
mohammed.ahmed5@med.helwan.edu.eg
First Name & Middle Initial & Last Name & Degree
Mohammed A Ammar, MD, MSc
First Name & Middle Initial & Last Name & Degree
Ahmed E Gaafar, MD, PHD
First Name & Middle Initial & Last Name & Degree
Khaled A Shams, MD, PHD
First Name & Middle Initial & Last Name & Degree
Arafa G Mohamed, MD, PHD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
"De-identified individual participant data collected during the COLCHICINE-PROTECT trial will be shared at 2 years after article publication with no end date. These data will be available to researchers who provide a methodologically sound proposal for the purposes of achieving specific aims outlined in that proposal. Proposals should be directed to Mohammed A Ammar via email (mohammed.ahmed5@med.helwan.edu.eg) and will be reviewed by the COLCHICINE-PROTECT study management committee. Requests to access data to undertake hypothesis-driven research will not be unreasonably withheld. To gain access, data requesters will need to sign a data access agreement and to confirm that data will only be used for the agreed purpose for which access was granted."
IPD Sharing Time Frame
at 2 years after article publication with no end date.
IPD Sharing Access Criteria
These data will be available to researchers who provide a methodologically sound proposal for the purposes of achieving specific aims outlined in that proposal. Proposals should be directed to Mohammed A Ammar via email (mohammed.ahmed5@med.helwan.edu.eg) and will be reviewed by the COLCHICINE-PROTECT study management committee. Requests to access data to undertake hypothesis-driven research will not be unreasonably withheld. To gain access, data requesters will need to sign a data access agreement and to confirm that data will only be used for the agreed purpose for which access was granted."
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Colchicine Protective Effect in Patients Undergoing Percutaneous Coronary Intervention (COLCHICINE-PROTECT)

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