Intravenous Tirofiban Versus Alteplase Before Mechanical Thrombectomy in Stroke (ADJUVANT)

December 27, 2023 updated by: Zhongming Qiu, Xinqiao Hospital of Chongqing

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

800

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Hangzhou First People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18 years or older.
  2. Presenting with acute ischemic stroke symptom.

  3. 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.
  4. Eligible for intravenous thrombolysis.
  5. Occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery, vertebrobasilar artery confirmed by CTA, MRA, or DSA.
  6. Informed consent obtained from patients or their legal representatives.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional independence
Time Frame: 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)
90 days post-endovascular treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinqiao Hospital of Chongqing

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

February 2, 2023

First Submitted That Met QC Criteria

February 14, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADJUVANT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

After the primary results was published

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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