Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587737
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Colchicine for the Reduction of Dependency and Vascular Events After an Acute Intracerebral Hemorrhage
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Double-blind Randomized Placebo-controlled Phase III Study for Reducing Dependency and Cardiovascular Events with Oral Colchicine 05mg Once Daily Compared with Placebo in Participants with Spontaneous Intracerebral Hemorrhage and Established or Risk Factors For Atherosclerosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CoVasc-ICH 2
Brief Summary:
Data indicate that patients with intracerebral hemorrhage ICH are at high risk for thromboembolic events and disability that is not being sufficiently mitigated by current treatment strategies This is aggravated by the cessation of antithrombotic medications for significant periods after hemorrhage These findings highlight the need for novel treatments that modify the high risk for major vascular events and functional outcomes in ICH survivors
The objective of CoVasc-ICH 2 is to demonstrate that oral colchicine 05 mg daily is superior to placebo for improving the outcomes of ICH survivors with evidence or risk factors for atherosclerosis when started within 72 hours from ICH onset
The objective of CoVasc-ICH 2 is to demonstrate that oral colchicine 05 mg daily is superior to placebo for improving the outcomes of ICH survivors with evidence or risk factors for atherosclerosis when started within 72 hours from ICH onset
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None