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

NCT05739929 | Unknown Phase 3 DMC

• 1 other identifier: 120-2022
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; Acute Coronary Syndrome; Percutaneous Coronary Intervention; Colchicine; Myocardial Injury; Inflammation; Myocardial Infarction; No Reflow

Outcome Measures

Primary Outcomes (1)

• 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

  6 hours after PCI

Secondary Outcomes (3)

• PCI associated inflammation

  6 hours after PCI

• No reflow phenomenon

  During the PCI procedure

• PCI-related (type 4a) Myocardial Infarction (MI)

  6 hours after PCI

Study Arms (2)

Colchicine

ACTIVE COMPARATOR

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

Drug: Colchicine 0.5 MG Oral Tablet

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

Colchicine 0.5 MG Oral Tablet DRUG

0.5 mg colchicine tablets twice daily.

Also known as: Colcrys, Gloperba, Mitigare

Colchicine

Placebo DRUG

Placebo tablets twice daily

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Helwan University Hospital

Helwan, Cairo Governorate, 11795, Egypt

RECRUITING

Related Publications (14)

• Kwaijtaal M, van Diest R, Bar FW, van der Ven AJ, Bruggeman CA, de Baets MH, Appels A. Inflammatory markers predict late cardiac events in patients who are exhausted after percutaneous coronary intervention. Atherosclerosis. 2005 Oct;182(2):341-8. doi: 10.1016/j.atherosclerosis.2005.02.022. Epub 2005 Mar 24.

  PMID: 16159607 BACKGROUND

• Writing Committee Members; Lawton JS, Tamis-Holland JE, Bangalore S, Bates ER, Beckie TM, Bischoff JM, Bittl JA, Cohen MG, DiMaio JM, Don CW, Fremes SE, Gaudino MF, Goldberger ZD, Grant MC, Jaswal JB, Kurlansky PA, Mehran R, Metkus TS Jr, Nnacheta LC, Rao SV, Sellke FW, Sharma G, Yong CM, Zwischenberger BA. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 Jan 18;79(2):e21-e129. doi: 10.1016/j.jacc.2021.09.006. Epub 2021 Dec 9.

  PMID: 34895950 BACKGROUND

• Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.

  PMID: 30165437 BACKGROUND

• Novack V, Pencina M, Cohen DJ, Kleiman NS, Yen CH, Saucedo JF, Berger PB, Cutlip DE. Troponin criteria for myocardial infarction after percutaneous coronary intervention. Arch Intern Med. 2012 Mar 26;172(6):502-8. doi: 10.1001/archinternmed.2011.2275. Epub 2012 Feb 27.

  PMID: 22371874 BACKGROUND

• Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). J Am Coll Cardiol. 2018 Oct 30;72(18):2231-2264. doi: 10.1016/j.jacc.2018.08.1038. Epub 2018 Aug 25. No abstract available.

  PMID: 30153967 BACKGROUND

• Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Angelantonio ED, Franco OH, Halvorsen S, Richard Hobbs FD, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice: Developed by the Task Force for cardiovascular disease prevention in clinical practice with representatives of the European Society of Cardiology and 12 medical societies With the special contribution of the European Association of Preventive Cardiology (EAPC). Rev Esp Cardiol (Engl Ed). 2022 May;75(5):429. doi: 10.1016/j.rec.2022.04.003. No abstract available. English, Spanish.

  PMID: 35525570 BACKGROUND

• Cole J, Htun N, Lew R, Freilich M, Quinn S, Layland J. Colchicine to Prevent Periprocedural Myocardial Injury in Percutaneous Coronary Intervention: The COPE-PCI Pilot Trial. Circ Cardiovasc Interv. 2021 May;14(5):e009992. doi: 10.1161/CIRCINTERVENTIONS.120.009992. Epub 2021 May 18.

  PMID: 34003667 RESULT

• Fu C, Wang B. Colchicine administration for percutaneous coronary intervention: A meta-analysis of randomized controlled trials. Am J Emerg Med. 2021 Aug;46:121-125. doi: 10.1016/j.ajem.2021.02.039. Epub 2021 Feb 22.

  PMID: 33744748 RESULT

• 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 RESULT

• Hosseini SH, Talasaz AH, Alidoosti M, Tajdini M, Van Tassell BW, Etesamifard N, Kakavand H, Jalali A, Aghakouchakzadeh M, Gheymati A, Sadeghian M, Jenab Y. Preprocedural Colchicine in Patients With Acute ST-elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention: A Randomized Controlled Trial (PodCAST-PCI). J Cardiovasc Pharmacol. 2022 Oct 1;80(4):592-599. doi: 10.1097/FJC.0000000000001317.

  PMID: 35881907 RESULT

• Maron DJ, Hochman JS, Reynolds HR, Bangalore S, O'Brien SM, Boden WE, Chaitman BR, Senior R, Lopez-Sendon J, Alexander KP, Lopes RD, Shaw LJ, Berger JS, Newman JD, Sidhu MS, Goodman SG, Ruzyllo W, Gosselin G, Maggioni AP, White HD, Bhargava B, Min JK, Mancini GBJ, Berman DS, Picard MH, Kwong RY, Ali ZA, Mark DB, Spertus JA, Krishnan MN, Elghamaz A, Moorthy N, Hueb WA, Demkow M, Mavromatis K, Bockeria O, Peteiro J, Miller TD, Szwed H, Doerr R, Keltai M, Selvanayagam JB, Steg PG, Held C, Kohsaka S, Mavromichalis S, Kirby R, Jeffries NO, Harrell FE Jr, Rockhold FW, Broderick S, Ferguson TB Jr, Williams DO, Harrington RA, Stone GW, Rosenberg Y; ISCHEMIA Research Group. Initial Invasive or Conservative Strategy for Stable Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1395-1407. doi: 10.1056/NEJMoa1915922. Epub 2020 Mar 30.

  PMID: 32227755 RESULT

• Munk PS, Breland UM, Aukrust P, Skadberg O, Ueland T, Larsen AI. Inflammatory response to percutaneous coronary intervention in stable coronary artery disease. J Thromb Thrombolysis. 2011 Jan;31(1):92-8. doi: 10.1007/s11239-010-0471-7.

  PMID: 20373128 RESULT

• Nidorf SM, Fiolet ATL, Mosterd A, Eikelboom JW, Schut A, Opstal TSJ, The SHK, Xu XF, Ireland MA, Lenderink T, Latchem D, Hoogslag P, Jerzewski A, Nierop P, Whelan A, Hendriks R, Swart H, Schaap J, Kuijper AFM, van Hessen MWJ, Saklani P, Tan I, Thompson AG, Morton A, Judkins C, Bax WA, Dirksen M, Alings M, Hankey GJ, Budgeon CA, Tijssen JGP, Cornel JH, Thompson PL; LoDoCo2 Trial Investigators. Colchicine in Patients with Chronic Coronary Disease. N Engl J Med. 2020 Nov 5;383(19):1838-1847. doi: 10.1056/NEJMoa2021372. Epub 2020 Aug 31.

  PMID: 32865380 RESULT

• Tardif JC, Kouz S, Waters DD, Bertrand OF, Diaz R, Maggioni AP, Pinto FJ, Ibrahim R, Gamra H, Kiwan GS, Berry C, Lopez-Sendon J, Ostadal P, Koenig W, Angoulvant D, Gregoire JC, Lavoie MA, Dube MP, Rhainds D, Provencher M, Blondeau L, Orfanos A, L'Allier PL, Guertin MC, Roubille F. Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction. N Engl J Med. 2019 Dec 26;381(26):2497-2505. doi: 10.1056/NEJMoa1912388. Epub 2019 Nov 16.

  PMID: 31733140 RESULT

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome; Inflammation; Myocardial Infarction

Interventions

Colchicine; Tablets

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Mohammed A Ammar, MD, MSc

  Helwan University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed A Ammar, MD, MSc

CONTACT

+201000089300; mohammed.ahmed5@med.helwan.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Cardiology

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 22, 2023
• Study Start: March 1, 2023
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: at 2 years after article publication with no end date.
• 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."

Locations

EG (1)