Clinical trial NCT05739929: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Acute Coronary Syndrome
Percutaneous Coronary Intervention
Colchicine
Myocardial Injury
Inflammation
Myocardial Infarction
No Reflow
Lead sponsor: Helwan University
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

1. 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.
2. 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).
3. Evaluation of colchicine efficacy in preventing no-reflow phenomenon. Our hypothesis is that colchicine will decrease no reflow phenomenon in CCS patients undergoing PCI.
4. 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.

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.

Primary outcomes:
measure: PCI related myocardial injury
timeFrame: 6 hours after PCI
Secondary outcomes:
measure: PCI associated inflammation
timeFrame: 6 hours after PCI
measure: No reflow phenomenon
timeFrame: During the PCI procedure
measure: PCI-related (type 4a) Myocardial Infarction (MI)
timeFrame: 6 hours after PCI
Other outcomes:
Locations:
city: Helwan
country: Egypt
facility: Helwan University Hospital
state: Cairo
Study officials:
affiliation: Helwan University, Faculty of Medicine
name: Mohammed A Ammar, MD, MSc
role: PRINCIPAL_INVESTIGATOR
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