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

Sponsor

Helwan University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05739929

Collaborator

(none)

400

Enrollment

Location

Arms

Anticipated Duration (Months)

22.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Colchicine 0.5 MG Oral Tablet Drug: Placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Colchicine Protective Effect in Patients Undergoing Elective Percutaneous Coronary Intervention (COLCHICINE-PROTECT) A Randomized, Placebo-controlled, Double-blind Clinical Trial

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Aug 30, 2024

Anticipated Study Completion Date :

Aug 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Colchicine 0.5 mg colchicine tablets twice daily 72 to 48 hours before planned PCI	Drug: Colchicine 0.5 MG Oral Tablet 0.5 mg colchicine tablets twice daily. Other Names: Colcrys Gloperba Mitigare
Placebo Comparator: Placebo Matching placebo	Drug: Placebo Placebo tablets twice daily

Arm

Intervention/Treatment

Active Comparator: Colchicine

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

Drug: Colchicine 0.5 MG Oral Tablet

0.5 mg colchicine tablets twice daily.

Other Names:

Colcrys

Gloperba

Mitigare

Placebo Comparator: Placebo

Matching placebo

Drug: Placebo

Placebo tablets twice daily

Outcome Measures

Primary Outcome Measures

PCI related myocardial injury [6 hours after PCI]
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 [6 hours after PCI]
Post PCI hs-CRP
No reflow phenomenon [During the PCI procedure]
Defined as Thrombolysis in Myocardial Infarction (TIMI) flow grade of less than 3.
PCI-related (type 4a) Myocardial Infarction (MI) [6 hours after PCI]
According to the 4th Universal Definition of MI

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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