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Introduction <p>This prospective, single-arm pharmacodynamic study assessed the effect of colchicine (COLC) [Strides Pharma UK Ltd, Watford, Hertfordshire, England] 0.5&#xa0;mg administered orally once daily for 14 days on platelet reactivity with respect to aspirin reaction units (ARUs) and P2Y<sub>12</sub> reaction units (PRUs).</p> Methods <p>Twenty-two patients with stable coronary artery disease (CAD) on dual antiplatelet therapy (DAPT) with daily maintenance aspirin and clopidogrel were recruited. Baseline platelet function was evaluated with the VerifyNow™ ARU and PRU assays (Werfen, Bedford, MA, USA) and assessed post-completion of COLC 0.5&#xa0;mg once daily for 14&#xa0;days.</p> Results <p>In this study, the median ARU baseline score was 463, and post-COLC it was 436, which was not statistically significant (<i>p</i> = 0.485). The mean difference in scores was −18.31 (95% confidence interval [CI] −74.34 to 37.71, <i>p</i> = 0.504). At baseline, 27.3% of the patients had “aspirin resistance” or were non-responders, compared to 13.6% post-COLC (<i>p</i> = 0.423). The median baseline PRU score was 210, and post-COLC it was 199, which was also not statistically significant (<i>p</i> = 0.581). The mean difference in scores was −7.31 (95% CI −31.1 to 16.5, <i>p</i> = 0.530). At baseline, 50% of the patients had “clopidogrel resistance” or were non-responders, compared to 45.5% post-COLC (<i>p</i> = 0.999). Two patients experienced mild gastrointestinal upset during the trial without interruption of COLC, and there were no serious adverse events or treatment-emergent adverse events.</p> Conclusions <p>There were no significant differences in ARUs and PRUs post-COLC trial in patients with stable CAD. This pilot pharmacodynamic study could be clinically informative in patients on DAPT. Further studies are required to confirm these exploratory findings.</p> Trial registration <p>ClinicalTrials.gov identifier, NCT06567678, prospectively registered 20/8/2024.</p>

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The Effect of Colchicine on Platelet Function Profiles in Patients with Stable Coronary Artery Disease: The ECLIPSE Pilot Study

  • 期刊论文

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  • 发表日期：

    2025年1月18日

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  • Naveen Seecheran,
  • Kathryn Grimaldos,
  • Penelope McCallum,
  • Priya Ramcharan,
  • Jessica Kawall,
  • Arun Katwaroo,
  • Gabriella Grimaldos,
  • Valmiki Seecheran,
  • Cathy-Lee Jagdeo,
  • Salma Rafeeq,
  • Rajeev Seecheran,
  • Abel Leyva Quert,
  • Nafeesah Ali,
  • Lakshmipathi Peram,
  • Shastri Motilal,
  • Rishi Ramtahal,
  • Neal Bhagwandass,
  • Stanley Giddings,
  • Anil Ramlackhansingh,
  • Sherry Sandy

摘要

Introduction

This prospective, single-arm pharmacodynamic study assessed the effect of colchicine (COLC) [Strides Pharma UK Ltd, Watford, Hertfordshire, England] 0.5 mg administered orally once daily for 14 days on platelet reactivity with respect to aspirin reaction units (ARUs) and P2Y12 reaction units (PRUs).

Methods

Twenty-two patients with stable coronary artery disease (CAD) on dual antiplatelet therapy (DAPT) with daily maintenance aspirin and clopidogrel were recruited. Baseline platelet function was evaluated with the VerifyNow™ ARU and PRU assays (Werfen, Bedford, MA, USA) and assessed post-completion of COLC 0.5 mg once daily for 14 days.

Results

In this study, the median ARU baseline score was 463, and post-COLC it was 436, which was not statistically significant (p = 0.485). The mean difference in scores was −18.31 (95% confidence interval [CI] −74.34 to 37.71, p = 0.504). At baseline, 27.3% of the patients had “aspirin resistance” or were non-responders, compared to 13.6% post-COLC (p = 0.423). The median baseline PRU score was 210, and post-COLC it was 199, which was also not statistically significant (p = 0.581). The mean difference in scores was −7.31 (95% CI −31.1 to 16.5, p = 0.530). At baseline, 50% of the patients had “clopidogrel resistance” or were non-responders, compared to 45.5% post-COLC (p = 0.999). Two patients experienced mild gastrointestinal upset during the trial without interruption of COLC, and there were no serious adverse events or treatment-emergent adverse events.

Conclusions

There were no significant differences in ARUs and PRUs post-COLC trial in patients with stable CAD. This pilot pharmacodynamic study could be clinically informative in patients on DAPT. Further studies are required to confirm these exploratory findings.

Trial registration

ClinicalTrials.gov identifier, NCT06567678, prospectively registered 20/8/2024.