Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, Acute Coronary Syndrome, Percutaneous Coronary Intervention, Colchicine, Myocardial Injury, Inflammation, Myocardial Infarction, No Reflow
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.
Interventions
0.5 mg colchicine tablets twice daily.
DRUGPlacebo
Placebo tablets twice daily
Sponsors
Helwan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Contacts
Primary ContactMohammed A Ammar, MD, MSc
Outcome results
None listed