EXtending the tIme Window of Thrombolysis by ButyphThalide up to 6 Hours After Onset (EXIT-BT)

• Sponsor: General Hospital of Shenyang Military Region (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05189509
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 10.6
• Patients Per Site Per Month: 9.5

Study Details

Study Description

Brief Summary

To date, the time window of intravenous thrombolysis is limited within 4.5 hours of stroke onset. Although EXTEND study has proved that intravenous thrombolysis can be extended from 4.5 to 9 hours, but the eligible patients must be selected by CTP. Thus, it is of clinical importance how to extend the time window of intravenous thrombolysis, which can benifit more patients. The current trial aims to investigate the effect of intravenous thrombolysis with TNK from 4.5 to 6 hours in ischemic stroke with help of Butyphthalide, which was found to be neuroprotective.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Ischemic	Drug: TNK-Tissue Plasminogen Activator	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: EXtending the tIme Window of Thrombolysis by ButyphThalide up to 6 Hours After Onset (EXIT-BT): a Prospective, Randomized, Blinded Assessment of Outcome and Open Label Multi-center Study
• Actual Study Start Date: Feb 11, 2022
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TNK group intravenous thrombolysis with 0.25 mg/kg TNK, with the biggest dose of 25 mg	Drug: TNK-Tissue Plasminogen Activator; 0.25 mg TNK thrombolysis
Placebo Comparator: control group	Drug: TNK-Tissue Plasminogen Activator; 0.25 mg TNK thrombolysis

Outcome Measures

Primary Outcome Measures

1. symptomatic intracerebral hemorrhage [36 hours]

   any evidence of bleeding on the head CT scan associated with clinically significant neurological deterioration (NIHSS score ≥4 points increase)

Secondary Outcome Measures

1. The proportion of excellent prognosis (mRS 0-1) [Day 90]

   the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome

2. The proportion of favourable prognosis (mRS 0-2) [Day 90]

   the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome

3. Distribution of modified Rankin Score [Day 90]

   the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome

4. Changes in National Institute of Health stroke scale (NIHSS) [24 hours, 2 weeks]

   the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome

5. any intracerebral hemorrhage [36 hours]

   the evidence of bleeding on the head CT scan

6. any cerebral microbleeding(CMB) [48 hours]

   CMB is measured by SWI sequence

7. infarct volume [48 hours]

   infarct volume is measured by DWI sequence

8. proportion of death [Day 90]

   death due to any cause

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age: 18-80;

• ischemic stroke confirmed by brain CT or MRI

• the time from onset to treatment: 4.5-6 hours

• NIHSS≥4

• prestroke mRS≤1

• signed informed consent

Exclusion Criteria:

• prestroke mRS≥2

• planned endovascular treatment

• planned intravenous thrombolysis based on WAKE-UP or EXTEND study criterion

• any contraindiction of intravenous thrombolysis

• other unsuitable conditions judged by investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Neurology, General Hospital of Northern Theater Command	Shenyang		China	110016

Sponsors and Collaborators

• General Hospital of Shenyang Military Region

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hui-Sheng Chen, Head of Neurology, General Hospital of Shenyang Military Region
• ClinicalTrials.gov Identifier: NCT05189509
• Other Study ID Numbers: y (2021) 110
• First Posted: Jan 12, 2022
• Last Update Posted: Feb 14, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ischemic Stroke; Plasminogen; Tissue Plasminogen Activator

Study Results

No Results Posted as of Feb 14, 2022