Colchicine in High-risk Patients with Acute Minor-to-moderate Ischemic Stroke or Transient Ischemic Attack (CHANCE-3) : Rationale and design of a multicenter randomized placebo-controlled trial
BACKGROUND: Anti-inflammatory therapy using colchicine has reduced recurrent vascular events in patients with coronary heart disease.
DESIGN: Colchicine in High-risk Patients with Acute Minor-to-moderate Ischemic Stroke or Transient Ischemic Attack (CHANCE-3) is a randomized, double-blind, placebo-controlled multicenter trial, in which 8,238 patients with acute minor-to-moderate ischemic stroke (NIHSS ⩽ 5) or high-risk transient ischemic attack (TIA) (ABCD2 score ⩾4) and a high-sensitivity CRP (hsCRP) level of ⩾2 mg/L will be randomly assigned within 24 h of symptom onset to colchicine (1 mg daily on days 1-3, followed by 0.5 mg daily for a total of 90 days) or matching placebo, on a background of optimal medical therapy. The study will have 90% power to detect a 25% reduction in the primary efficacy outcome of any stroke within 3 months of randomization. Adverse events potentially related to the use of colchicine will also be analyzed. The primary analysis will be by intention to treat.
TRIAL REGISTRY NAME: Colchicine in High-risk Patients with Acute Minor-to-moderate Ischemic Stroke or Transient Ischemic Attack (CHANCE-3); URL: https://clinicaltrials.gov/ct2/show/NCT05439356?cond=CHANCE-3&draw=2&rank=1; Registration number: NCT05439356.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:18 |
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| Enthalten in: |
International journal of stroke : official journal of the International Stroke Society - 18(2023), 7 vom: 15. Aug., Seite 873-878 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Wang, Yongjun [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 27.07.2023 Date Revised 27.07.2023 published: Print-Electronic ClinicalTrials.gov: NCT05439356 Citation Status MEDLINE |
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| doi: |
10.1177/17474930231172312 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM355644142 |
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| 245 | 1 | 0 | |a Colchicine in High-risk Patients with Acute Minor-to-moderate Ischemic Stroke or Transient Ischemic Attack (CHANCE-3) |b Rationale and design of a multicenter randomized placebo-controlled trial |
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| 500 | |a Date Revised 27.07.2023 | ||
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| 500 | |a ClinicalTrials.gov: NCT05439356 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: Anti-inflammatory therapy using colchicine has reduced recurrent vascular events in patients with coronary heart disease | ||
| 520 | |a DESIGN: Colchicine in High-risk Patients with Acute Minor-to-moderate Ischemic Stroke or Transient Ischemic Attack (CHANCE-3) is a randomized, double-blind, placebo-controlled multicenter trial, in which 8,238 patients with acute minor-to-moderate ischemic stroke (NIHSS ⩽ 5) or high-risk transient ischemic attack (TIA) (ABCD2 score ⩾4) and a high-sensitivity CRP (hsCRP) level of ⩾2 mg/L will be randomly assigned within 24 h of symptom onset to colchicine (1 mg daily on days 1-3, followed by 0.5 mg daily for a total of 90 days) or matching placebo, on a background of optimal medical therapy. The study will have 90% power to detect a 25% reduction in the primary efficacy outcome of any stroke within 3 months of randomization. Adverse events potentially related to the use of colchicine will also be analyzed. The primary analysis will be by intention to treat | ||
| 520 | |a TRIAL REGISTRY NAME: Colchicine in High-risk Patients with Acute Minor-to-moderate Ischemic Stroke or Transient Ischemic Attack (CHANCE-3); URL: https://clinicaltrials.gov/ct2/show/NCT05439356?cond=CHANCE-3&draw=2&rank=1; Registration number: NCT05439356 | ||
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| 650 | 4 | |a Ischemic stroke | |
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| 700 | 1 | |a Easton, J Donald |e verfasserin |4 aut | |
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| 700 | 1 | |a Zhao, Xingquan |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Zixiao |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Liping |e verfasserin |4 aut | |
| 700 | 1 | |a Gu, Hongqiu |e verfasserin |4 aut | |
| 700 | 1 | |a Jiang, Yong |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Anxin |e verfasserin |4 aut | |
| 700 | 1 | |a Pan, Yuesong |e verfasserin |4 aut | |
| 700 | 1 | |a Jing, Jing |e verfasserin |4 aut | |
| 700 | 1 | |a Niu, Siying |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Hao |e verfasserin |4 aut | |
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