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Tenecteplase or Reteplase as Bridging Thrombolysis Before Thrombectomy in Acute Ischemic Cerebrovascular Events

ConditionsAcute Ischemic StrokeLarge Vessel OcclusionAnterior Circulation Brain Infarction
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorYongjun Wang

About this trial

Acute ischemic stroke caused by large vessel occlusion (LVO) is a major cause of disability, and mechanical thrombectomy (MT) has become the standard treatment for eligible patients. However, the optimal role of intravenous thrombolysis before MT remains uncertain.

The TRACE-BRIDGE trial is a phase 3, investigator-initiated, multicenter, randomized, open-label trial with blinded outcome assessment (PROBE design) evaluating different bridging thrombolysis strategies before MT. The trial will enroll adults with acute ischemic stroke presenting within 4.5 hours of symptom onset and with imaging-confirmed anterior circulation LVO who are eligible for intravenous thrombolysis and MT.

Participants will be randomly assigned in a 1:1:1 ratio to receive tenecteplase plus MT, reteplase plus MT, or direct MT alone. The TRACE-BRIDGE trial aims to evaluate the efficacy and safety of bridging thrombolysis with tenecteplase or reteplase before mechanical thrombectomy compared with direct mechanical thrombectomy. The primary outcome is functional independence, defined as a modified Rankin Scale score of 0-2 at 90 days after randomization. If superiority of bridging thrombolysis is demonstrated, the trial will further evaluate whether reteplase is non-inferior to tenecteplase as a bridging thrombolytic strategy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with acute ischemic stroke presenting within 4.5 hours of symptom onset who are eligible for intravenous thrombolytic therapy. A baseline non-contrast CT or MRI is required for screening.

Large vessel occlusion on computed tomographic angiography (CTA) or magnetic resonance angiography (MRA) of the intracranial carotid artery (ICA) or middle cerebral artery (MCA) M1

Age ⩾ 18 years at the time of signing the informed consent form

ASPECTS 6-10

Disqualifiers

Intracranial hemorrhage (ICH) identified by CT or MRI

Rapidly improving symptoms at the discretion of the investigator

mRS > 2 before stroke onset.

Massive cerebral infarction (infarct size greater than one-third of the blood middle cerebral artery supply area) suggested by CT.

Trial design

Design model

Parallel

Treatments tested in this trial

  • rhTNK-tPA (0.25mg/kg)

    Drug

    Recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA) administered as a single intravenous bolus at a dose of 0.25 mg/kg (maximum dose 25 mg) within 4.5 hours of symptom onset prior to mechanical thrombectomy.

  • Reteplase 10 Units (U) plus a second dose of reteplase 10 U

    Drug

    Two intravenous bolus injections of 18 mg each, administered within 4.5 hours of onset over approximately 2 minutes per bolus, separated by a 30-minute interval prior to thrombectomy. To avoid delays in reperfusion therapy, groin puncture and MT procedures may be initiated after administration of the first 18 mg bolus, without waiting for completion of the second bolus. Unless contraindicated, the second rPA bolus should be administered according to the scheduled dosing regimen irrespective of EVT status.

  • No thrombolysis (thrombectomy alone)

    Procedure/Surgery

    Patients will undergo mechanical thrombectomy according to standard practice, without administration of intravenous thrombolytic agents.

Treatment groups

1,440 Participants
are divided into 3 treatment groups
Group A: rhTNK-tPA+MTExperimental treatment 1 intervention
Group B: rPA+MTExperimental treatment 1 intervention
Group C: MT aloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Functional Independence

Proportion of participants achieving functional independence, defined as a modified Rankin Scale (mRS) score of 0-2 at 90 days after randomization. The mRS ranges from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability.

Time frame
From randomization to 90 days after randomization (±7 days), with outcome assessment performed by blinded assessors.

Secondary outcomes

1

Excellent functional outcome

Proportion of participants achieving an excellent functional outcome, defined as a modified Rankin Scale (mRS) score of 0-1 at 90 days after randomization. The mRS ranges from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability.

Time frame
From randomization to 90 days after randomization (±7 days), with outcome assessment performed by blinded assessors.
2

Favorable functional outcome

Proportion of participants achieving a favorable functional outcome, defined as a modified Rankin Scale (mRS) score of 0-3 at 90 days after randomization. The mRS ranges from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability.

Time frame
90 days after randomization (±7 days), assessed by blinded outcome assessors.
3

Early neurological improvement

Proportion of participants achieving major early neurological recovery at 24 hours after randomization, defined as a reduction in National Institutes of Health Stroke Scale (NIHSS) score from baseline of ≥8 points or an NIHSS score of 0-1. The NIHSS ranges from 0 (no neurological deficit) to 42 (maximum neurological impairment), with higher scores indicating greater neurological impairment.

Time frame
22-36 hours after randomization
4

Neurological improvement

Proportion of participants achieving neurological improvement at day 7 or discharge, whichever occurs first, defined as a reduction in National Institutes of Health Stroke Scale (NIHSS) score from baseline of ≥8 points or an NIHSS score of 0-1. The NIHSS ranges from 0 (no neurological deficit) to 42 (maximum neurological impairment), with higher scores indicating greater neurological impairment.

Time frame
Day 7 after randomization or discharge, whichever occurs first (±1 day)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yongjun Wang

Lead sponsor

Beijing Tiantan Hospital

Sponsor institution

Source ClinicalTrials.gov

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