ADJUVANT: Intravenous Tirofiban Versus Alteplase Before Mechanical Thrombectomy in Stroke

Sponsor

Xinqiao Hospital of Chongqing (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05728333

Collaborator

Zhejiang University (Other)

800

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

In patients with acute ischemic stroke secondary to large vessel occlusion, the role of intravenous adjunctive medications, such as tirofiban, or alteplase before endovascular thrombectomy has not been well investigated. This trial aim to evaluate the efficacy and safety of intravenous tirofiban versus alteplase for acute ischemic stroke patients with large vessel occlusion piror to endovascular thrombectomy.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute Ischemic	Drug: Tirofiban Drug: Alteplase	Phase 2/Phase 3

Detailed Description

Intravenous alteplase bridging with endovascular treatment (EVT) has been proven to be effective therapy in acute ischemic stroke patients due to large vessel occlusion (LVO). Several randomized controlled trials, aiming to explore the benefits and risks of intravenous alteplase prior to EVT in LVO stroke, have suggested that intravenous alteplase should not be omitted. Although intravenous alteplase results in successful reperfusion in approximately 10% to 20% of LVO patients, obviating the need for EVT, it has limitations. First, the time window for intravenous alteplase is narrow with strict indications and contraindications. Second, it may increase the risk of intracranial hemorrhage. Furthermore, alteplase is expensive. The above limitations lead to a very low proportion of patients who receive intravenous thrombolysis. Tirofiban is a selective IIb/IIIa receptor inhibitor, and it's effective in preventing thrombosis complications. Intravenous tirofiban has been increasingly used as an adjunctive treatment in acute ischemic stroke patients receiving EVT. However, a direct comparison between tirofiban and alteplase in LVO stroke has not been performed. We therefore conduct a randomized controlled trials to evaluate the efficacy and safety of intravenous tirofiban versus alteplase prior to EVT for acute ischemic stroke patients with LVO.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Intravenous Adjuvant With Tirofiban Versus Alteplase Before Mechanical Thrombectomy in Acute Ischemic Stroke Patients With Large Vessel Occlusion: a Multicenter, Open Label, Randomized Controlled Trial.

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2027

Anticipated Study Completion Date :

Jun 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tirofiban Tirofiban will be administrated intravenously before endovascular thrombectomy.	Drug: Tirofiban Intravenous tirofiban before endovascular thrombectomy. Other Names: Tirofiban & EVT
Active Comparator: Alteplase Alteplase will be administrated intravenously before endovascular thrombectomy.	Drug: Alteplase Intravenous alteplase before endovascular thrombectomy. Other Names: Alteplase & EVT

Arm

Intervention/Treatment

Experimental: Tirofiban

Tirofiban will be administrated intravenously before endovascular thrombectomy.

Drug: Tirofiban

Intravenous tirofiban before endovascular thrombectomy.

Other Names:

Tirofiban & EVT

Active Comparator: Alteplase

Alteplase will be administrated intravenously before endovascular thrombectomy.

Drug: Alteplase

Intravenous alteplase before endovascular thrombectomy.

Other Names:

Alteplase & EVT

Outcome Measures

Primary Outcome Measures

Functional independence [90 days post-endovascular treatment]
modified Rankin scale score of 0 to 2. (The modified Rankin scale scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Aged 18 years or older.
Presenting with acute ischemic stroke symptom.
Time from onset to hospital arrival:

(1) within 4.5 hours
(2) 4.5-9.0 hours, image inclusion criteria for the EXTEND trial must be met
(3) > 4.5 hours but within 24 hours, image inclusion criteria for the WAKE-UP trial must be met.

Eligible for intravenous thrombolysis.
Occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery, vertebrobasilar artery confirmed by CTA, MRA, or DSA.
Informed consent obtained from patients or their legal representatives.

Exclusion Criteria:

CT or MR evidence of hemorrhage (the presence of micro-bleeds is allowed);
Contraindications of IV rt-PA or tirofiban;
Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys;
Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;
Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
CT or MRI evidence of mass effect or intracranial tumor (except small eningioma);
CT or MRI evidence of cerebral vasculitis;
CTA or MRA evidence of intracranial arteriovenous malformations or aneurysms;
Any terminal illness with life expectancy less than 6 months.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Xinqiao Hospital of Chongqing
Zhejiang University

Investigators

Principal Investigator: Congguo Yin, Doctor, Hangzhou First Hospital of Zhejiang University
Principal Investigator: Zhongming Qiu, Doctor, The 903rd Hospital of PLA, China