Ignite Creation Date:
2024-05-05 @ 10:53 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01204333
Status:
TERMINATED
Last Update Posted:
2017-02-14
First Post:
2010-09-15
Brief Title:
Thrombolysis or Anticoagulation for Cerebral Venous Thrombosis
Sponsor:
Jan Stam MD PhD
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Thrombolysis or Anticoagulation for Cerebral Venous Thrombosis TOACT
Status:
TERMINATED
Status Verified Date:
2016-11
Last Known Status:
None
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:
TOACT
Brief Summary:
Background Endovascular thrombolysis with or without mechanical clot removal ET may be beneficial for a subgroup of patients with cerebral venous sinus thrombosis CVT who have a poor prognosis despite treatment with heparin Published experience with ET is promising but only based on case series and not on controlled trials
Objective The main objective of the TO-ACT trial is to determine if ET improves the functional outcome of patients with a severe form of CVT
Study design The TO-ACT trial will be designed as a multi-centre prospective randomized open-label blinded endpoint PROBE trial
Study population Patients are eligible if they have a radiologically proven CVT a high probability of poor outcome defined by presence of one or more of the following risk factors mental status disorder coma intracranial hemorrhagic lesion or thrombosis of the deep cerebral venous system and the responsible physician is uncertain if ET or standard anti-coagulant treatment is better
Intervention Patients will be randomized to receive either ET or standard therapy therapeutic doses of heparin ET consists of local application of alteplase or urokinase within the thrombosed sinuses andor mechanical thrombectomy Glasgow coma score NIH stroke scale and relevant laboratory parameters will be assessed at baseline
Endpoints The primary endpoint is the modified Rankin scale mRS at 12 months The most important secondary outcomes are the mRS mortality and recanalization rate at 6 months Major intra- and extracranial hemorrhagic complications within one week following the intervention are the principal safety outcome Results will be analyzed according to the intention-to-treat principle Assessment of study endpoints will be carried out according to standardized questionnaires by a blinded neurologist or research nurse who is not involved in the treatment of the patient
Study size To detect a 50 relative reduction in mRS2 from 40 to 20 164 patients 82 in each treatment arm have to be included two-sided alpha 80 power
Nature and extent of the burden and risks associated with participation benefit and group relatedness Included patients may benefit directly from ET Complications of ET most notably intracranial hemorrhages constitute the most important risk of the study
Objective The main objective of the TO-ACT trial is to determine if ET improves the functional outcome of patients with a severe form of CVT
Study design The TO-ACT trial will be designed as a multi-centre prospective randomized open-label blinded endpoint PROBE trial
Study population Patients are eligible if they have a radiologically proven CVT a high probability of poor outcome defined by presence of one or more of the following risk factors mental status disorder coma intracranial hemorrhagic lesion or thrombosis of the deep cerebral venous system and the responsible physician is uncertain if ET or standard anti-coagulant treatment is better
Intervention Patients will be randomized to receive either ET or standard therapy therapeutic doses of heparin ET consists of local application of alteplase or urokinase within the thrombosed sinuses andor mechanical thrombectomy Glasgow coma score NIH stroke scale and relevant laboratory parameters will be assessed at baseline
Endpoints The primary endpoint is the modified Rankin scale mRS at 12 months The most important secondary outcomes are the mRS mortality and recanalization rate at 6 months Major intra- and extracranial hemorrhagic complications within one week following the intervention are the principal safety outcome Results will be analyzed according to the intention-to-treat principle Assessment of study endpoints will be carried out according to standardized questionnaires by a blinded neurologist or research nurse who is not involved in the treatment of the patient
Study size To detect a 50 relative reduction in mRS2 from 40 to 20 164 patients 82 in each treatment arm have to be included two-sided alpha 80 power
Nature and extent of the burden and risks associated with participation benefit and group relatedness Included patients may benefit directly from ET Complications of ET most notably intracranial hemorrhages constitute the most important risk of the study
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