Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125671
Status:
UNKNOWN
Last Update Posted:
2009-09-29
First Post:
2005-07-29
Brief Title:
Warfarin and Antiplatelet Vascular Evaluation
Sponsor:
Anand Sonia MD
Organization:
Warfarin and Antiplatelet Vascular Evaluation
Study Overview
Official Title:
A Phase III Randomized Trial of Warfarin Plus Antiplatelet Therapy Versus Antiplatelet Therapy Alone in Patients With Peripheral Vascular Disease
Status:
UNKNOWN
Status Verified Date:
2009-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate whether the addition of warfarin a blood-thinning medication to an antiplatelet therapy like aspirin is better than antiplatelet therapy alone ie usual treatment for the prevention of leg surgery heart attacks stroke and death in people with peripheral vascular disease
Detailed Description:
Atherosclerosis is the underlying cause of peripheral vascular disease PVD of the lower extremities and leads to intermittent claudication leg ulceration and gangrene More importantly symptomatic PVD is an ominous sign that widespread atherosclerosis is present and patients with this condition suffer a threefold increase in myocardial infarction MI stroke and CV death These CV events are a consequence of rupture of an atherosclerotic plaque which leads to platelet activation and thrombin generation thrombus formation and occlusion of a critical blood vessel Antiplatelet therapy has been clearly demonstrated to reduce major CV events It is also reasonable to expect that this process may be further attenuated by the addition of an anti-thrombin agent such as warfarin in combination with antiplatelet agents
WAVE is a large international multicentre randomized clinical trial in high-risk PVD patients to evaluate the additional benefit of moderate intensity warfarin target INR of 24-30 to antiplatelet therapy compared to antiplatelet therapy alone in reducing serious cardiovascular events
There are currently 80 active centres following participants in Canada Poland Australia Hungary China Ukraine and the Netherlands Following randomization to one of the two treatment groups participants will require clinic or phone follow-up visits every 3 months for 25 or 35 years For participants on warfarin INRs will be measured monthly or more frequently if required For participants who stop warfarin therapy prematurely every attempt will be made to have them restart it
WAVE is a large international multicentre randomized clinical trial in high-risk PVD patients to evaluate the additional benefit of moderate intensity warfarin target INR of 24-30 to antiplatelet therapy compared to antiplatelet therapy alone in reducing serious cardiovascular events
There are currently 80 active centres following participants in Canada Poland Australia Hungary China Ukraine and the Netherlands Following randomization to one of the two treatment groups participants will require clinic or phone follow-up visits every 3 months for 25 or 35 years For participants on warfarin INRs will be measured monthly or more frequently if required For participants who stop warfarin therapy prematurely every attempt will be made to have them restart it
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| T4913 | None | None | None |