Endovascular Treatment With Versus Without Intravenous rhTNK-tPA in Stroke (BRIDGE-TNK)

Army Medical University of People's Liberation Army

Status and phase: Completed; Phase 3; Phase 2

Conditions: Stroke, Acute; Stroke, Ischemic

Treatments: Other: Endovascular treatment; Drug: rhTNK-tPA

Study type: Interventional

Funder types: Other

Identifiers

NCT04733742

BRIDGE-TNK

Details and patient eligibility

About

The purpose of this trial is to investigate whether intravenous rhTNK-tPA prior to endovascular treatment can improve 90-day functional outcome of stroke patients with large vessel occlusion who are thrombolysis-eligible within 4.5 hours of symptom onset.

Full description

The DEVT, SKIP and DIRECT-MT trials showed that endovascular treatment alone is not inferior to intravenous alteplase bridging with endovascular treatment in terms of achieving 90-day functional independence for stroke patients with large vessel occlusion. The EXTEND-IA TNK part 1 and part 2 demonstrated that intravenous thrombolysis with tenecteplase is superior to alteplase before endovascular treatment. However, it is unclear whether intravenous tenecteplase bridging with endovascular treatment is superior to endovascular treatment alone. The purpose of this trial is to investigate whether intravenous rhTNK-tPA bridging with endovascular treatment is better than endovascular treatment alone for stroke patients with large vessel occlusion who are thrombolysis-eligible within 4.5 hours of onset.

Enrollment: 550 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18 years or older;
2. Patient with acute ischemic stroke who is eligible for intravenous thrombolysis treatment within 4.5 hours of time last known well;
3. No significant prestroke functional disability: for age <80 years, prestroke modified Rankin scale (mRS) ≤2; for age ≥80 years, prestroke mRS ≤1;
4. MCA-M1 or -M2, basilar artery, or posterior cerebral artery-P1 occlusion proved by CTA/MRA;
5. EVT is planned by clinical care team;
6. Written informed consent is obtained from patients and/or their legal representatives.

Exclusion criteria

1. Intracranial hemorrhage on baseline CT or MR
2. Contraindication to intravenous thrombolytics
3. Already received intravenous thrombolytic after index stroke
4. Known pregnancy, or breastfeeding, or serum beta human chorionic gonadotropin test is positive on admission
5. Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys
6. Current participation in another investigational drug clinical trial
7. Arterial tortuosity and/or other arterial disease that would lead to unstable access platform or prevent the thrombectomy device from reaching the target vessel
8. Patient with a preexisting neurological or psychiatric disease that would confound the outcome assessments
9. Patient with occlusions in two or more vascular territories (e.g. bilateral territories, or anterior and posterior circulation)
10. Mass effect or intracranial neoplasm on baseline CT or MR (except small meningioma)
11. Intracranial arteriovenous malformation or aneurysm on baseline CT or MR angiography
12. Any terminal disease with a life expectancy less than half a year
13. Unlikely to be available for follow-up at 90 days.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

550 participants in 2 patient groups

Conbined treatment group

Experimental group

Description:

intravenous tenecteplase bridging with endovascular treatment

Treatment:

Drug: rhTNK-tPA

Other: Endovascular treatment

Endovascular treatment alone group

Active Comparator group

Description:

endovascular treatment alone

Treatment:

Other: Endovascular treatment