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NCT01709981 · ClinicalTrials.gov registry record · Phase 4
Anti-inflammatory Effects of Colchicine in PCI
A Phase 4 study of Coronary Artery Disease, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 280
- Enrollment target
- 3
- Study locations
NCT01709981 is a Phase 4 study of Coronary Artery Disease that has completed, run by NYU Langone Health. The registered enrollment target is 280 participants, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (78% lower). The trial reports 3 study locations across 1 state.
The verdict
NCT01709981, a Phase 4 study of Coronary Artery Disease, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 280 participants
- Enrollment target
- 3
- Study locations
Study Summary
Peri-procedural inflammation is associated with increased rates of post-procedural myocardial infarction (MI), which occur in up to 35% of PCI patients and are themselves associated with increased risk of later MI and death. Statins suppress both inflammatory markers and MI rates during and after PCI, but ≥ 40% of PCI patients go statin-untreated, due in part to side effects such as myalgia. Moreover, because their mechanism of action relies on post-translational effects, statins must be given ≥ 12 to 24 hours prior to PCI, a time frame that is not always feasible. The investigators propose a novel alternative approach to reduce inflammation during PCI employing colchicine, an anti-inflammatory medication used frequently in gout and pericarditis. Colchicine may be particularly applicable to the PCI setting due to its rapid onset of action and excellent side-effect profile at low doses, as well as its known mechanisms of action. However, data on colchicine use in patients with coronary disease is extremely limited, and no studies to date have evaluated the use of colchicine in patients undergoing PCI. The investigators aim to characterize a potential mechanism of benefit in patients undergoing PCI by evaluating the effects of colchicine on soluble and leukocyte surface markers after PCI. The investigators also aim to determine the effects of colchicine on peri-procedural myonecrosis and MI. Accordingly, the investigators propose a prospective randomized study to characterize the effect of colchicine on inflammation and peri-procedural myocnecrosis. Patients referred for possible PCI will be randomized in a double-blinded fashion to placebo or colchicine (1.2mg 1 to 2 hours before PCI, followed by 0.6mg 1 hour later). The primary endpoint will be post-procedural interleukin-6 level. Secondary endpoints will include other relevant soluble and leukocyte-associated inflammatory markers. Sample size needed is 200 patients undergoing PCI. To adjust for a floor effect, 280
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Colchicine
Study Locations (3)
New York
- Manhattan VA Hospital - New York
- Bellevue Hospital Center - New York
- New York Langone Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2013-05-30 |
| Est. Completion | 2021-12-13 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01709981
The ClinicalTrials.gov registry entry for NCT01709981 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (78% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01709981 reports 3 study locations spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT01709981 about?
NCT01709981 is a clinical study titled "Anti-inflammatory Effects of Colchicine in PCI". Peri-procedural inflammation is associated with increased rates of post-procedural myocardial infarction (MI), which occur in up to 35% of PCI patients and are themselves associated with increased risk of later MI and death. Statins suppress both inflammatory markers and MI rates during and after PC...
What is the current status of trial NCT01709981?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 280 participants. The study started on 2013-05-30. Estimated completion is 2021-12-13.
What conditions does trial NCT01709981 study?
This clinical trial studies the following conditions: Coronary Artery Disease.
What interventions are being tested in trial NCT01709981?
The interventions under investigation include: Placebo (DRUG), Colchicine (DRUG).
Who is sponsoring clinical trial NCT01709981?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01709981 being conducted?
This trial has 3 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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