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Coronary Artery DiseasePhase 3NCT05739929

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

A Phase 3 study testing Colchicine 0.5 MG Oral Tablet in people with Coronary Artery Disease, run by Helwan University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Colchicine 0.5 MG Oral Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
400 participants
Where
1 siteEgypt
Study dates
1 Mar 2023to 30 Aug 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Mohammed A Ammar, MD, MSc contact

+201000089300

mohammed.ahmed5@med.helwan.edu.eg

Egypt1 site, 1 recruiting

  • Helwan University Hospital

    Helwan, Cairo Governorate, 11795

    Mohammed A Ammar, MD, MSc, +201000089300, mohammed.ahmed5@med.helwan.edu.eg

    Mohammed A Ammar, MD, MSc

    Recruiting

Other trials in Egypt

About this study

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

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.

Read the 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.
Being tested
Colchicine 0.5 MG Oral Tablet, Placebo
Keywords
Coronary Artery Disease, Acute Coronary Syndrome, Percutaneous Coronary Intervention, Colchicine, Myocardial Injury, Inflammation, Myocardial Infarction, No Reflow
Medical subject headings
Coronary Artery Disease, Acute Coronary Syndrome, Inflammation, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Colchicine 0.5 MG Oral TabletDrug

    Also called Colcrys, Gloperba, Mitigare

    0.5 mg colchicine tablets twice daily.

  • PlaceboDrug

    Placebo tablets twice daily

Study groups in NCT05739929
Study groupRoleWhat they receive
ColchicineActive comparator0.5 mg colchicine tablets twice daily 72 to 48 hours before planned PCI
Receives: Drug: Colchicine 0.5 MG Oral Tablet
PlaceboPlacebo comparatorMatching placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 hours after PCI

Secondary outcomes (3)

  1. PCI associated inflammation

    Post PCI hs-CRP

    Measured: 6 hours after PCI

  2. No reflow phenomenon

    Defined as Thrombolysis in Myocardial Infarction (TIMI) flow grade of less than 3.

    Measured: During the PCI procedure

  3. PCI-related (type 4a) Myocardial Infarction (MI)

    According to the 4th Universal Definition of MI

    Measured: 6 hours after PCI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2023
  2. Study start1 Mar 2023
  3. Primary completion30 Aug 2024 (estimated)
  4. Study completion30 Aug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05739929
Sponsor's protocol ID
120-2022
Status last verified
Mar 2023
First submitted
13 Feb 2023
Last updated
22 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: "De-identified individual participant data collected during the COLCHICINE-PROTECT trial will be shared at 2 years after article publication with no end date. 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."

Publications

  • 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.

    PubMed 16159607

  • 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.

    PubMed 34895950

  • 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.

    PubMed 30165437

  • 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.

    PubMed 22371874

  • 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.

    PubMed 30153967

  • 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.

    PubMed 35525570

  • 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.

    PubMed 34003667

  • 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.

    PubMed 33744748

  • 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.

    PubMed 32295417

  • 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.

    PubMed 35881907

  • 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.

    PubMed 32227755

  • 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.

    PubMed 20373128

  • 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.

    PubMed 32865380

  • 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.

    PubMed 31733140

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Colchicine 0.5 MG Oral Tablet in people with Coronary Artery Disease, run by Helwan University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mohammed A Ammar, MD, MSc (+201000089300, mohammed.ahmed5@med.helwan.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PCI related myocardial injury (time frame: 6 hours after PCI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05739929, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.

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