Colchicine in Percutaneous Coronary Intervention

NCT02594111 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: CARB-025-15S
• Study Type: interventional
• Target: 714
• Locations: 1 country
• Sites: 1

Brief Summary

Inflammation in the arteries of the heart may increase the risk of cardiac death. The proposed research seeks to identify the potential beneficial role of a safe anti-inflammatory medication, colchicine, on reducing damage caused by opening up a blockage in the arteries of the heart. With its quick onset of action and excellent safety profile, colchicine may have the potential to reduce risk of major adverse events related to the heart. This research also seeks to better understand the role of neutrophils, the most common type of inflammatory white blood cell in the body, when there is damage to the heart.

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Keywords

inflammation; percutaneous coronary intervention; coronary artery disease; colchicine

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Peri-procedural Myocardial Necrosis

  troponin above the upper limit of normal (ULN)

  24 hours

Secondary Outcomes (7)

• Number of Participants With All-cause Mortality, Non-fatal MI, or Target Vessel Revascularization (TVR)

  30 days

• Number of Participants With All-cause Mortality, Non-fatal MI, or TVR

  1 year

• All-cause Mortality, Non-fatal MI, or TVR

  2 years

• All-cause Mortality, Non-fatal MI, or TVR

  3 years

• All-cause Mortality, Non-fatal MI, or TVR

  4 years

Study Arms (2)

Colchicine

ACTIVE COMPARATOR

Colchicine 1.8 mg PO over 1 hour

Drug: Colchicine vs Placebo

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Colchicine vs Placebo

Interventions

Colchicine vs Placebo DRUG

Colchicine vs Placebo 1.8 mg PO over 1 hour

Colchicine; Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Referred for possible PCI

You may not qualify if:

• Colchicine use within 1 month
• History of colchicine intolerance
• Glomerular filtration rate \<30mL/minute or on dialysis (due to the need to adjust colchicine dose in this setting)
• Active malignancy or infection (major confounder with increased inflammatory markers)
• History of myelodysplasia (due to suggested cautionary use of colchicine in this setting)
• High-dose statin load \<24 hours prior to procedure (major confounder that is known to reduce inflammatory levels in 12 to 24 hours)
• Use of anti-inflammatory agents (except aspirin) within 5 halflives of the individual drug
• Use of strong Cytochrome P450, Family 3, Subfamily A, Polypeptide 4 (CYP3A4) and/or P-glycoprotein inhibitors (e.g. ritonavir, ketoconazole, clarithromycin, cyclosporine, diltiazem and verapamil, again due to drug interactions)
• Unable to consent
• Participating in a competing study
• Any significant condition or situation that may put the subject at higher risk, confound the study results or interfere with adherence to study procedures

Sponsors & Collaborators

• VA Office of Research and Development: lead
• NYU Langone Health: collaborator

Study Sites (1)

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

New York, New York, 10010, United States

Location

Related Publications (2)

• Talmor N, Pillinger MH, Xia Y, Leonard A, Curovic F, Shah B. Neutrophil Activation and Adhesiveness in Coronary Artery Disease: Results From the COLCHICINE-PCI Biomarker Substudy. J Am Heart Assoc. 2024 Oct;13(19):e036701. doi: 10.1161/JAHA.124.036701. Epub 2024 Sep 30.

  PMID: 39344637 DERIVED

• Shah B, Pillinger M, Zhong H, Cronstein B, Xia Y, Lorin JD, Smilowitz NR, Feit F, Ratnapala N, Keller NM, Katz SD. Effects of Acute Colchicine Administration Prior to Percutaneous Coronary Intervention: COLCHICINE-PCI Randomized Trial. Circ Cardiovasc Interv. 2020 Apr;13(4):e008717. doi: 10.1161/CIRCINTERVENTIONS.119.008717. Epub 2020 Apr 16.

  PMID: 32295417 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome; Inflammation

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Binita Shah
• Organization: VA NY Harbor Healthcare System

binita.shah@va.gov

212-686-7500

Study Officials

• Binita Shah, MD

  Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2015
• First Posted: November 2, 2015
• Study Start: May 30, 2013
• Primary Completion: August 30, 2019
• Study Completion: December 31, 2021
• Last Updated: February 21, 2023
• Results First Posted: July 10, 2020

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)