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Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ

ConditionMinor Ischemic Stroke
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital

About this trial

The purpose of this study is to evaluate the efficacy and safety of intravenous tenecteplase (0.25 mg/kg) compared with standard therapy in patients with acute ischemic stroke presenting with mild symptoms-defined as a National Institutes of Health Stroke Scale (NIHSS) score ≤5 accompanied by persistent unilateral limb weakness or speech impairment within 4.5 hours of onset.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years;

Onset-to-treatment time < 4.5 h; onset time defined as "last known well" time;

Clinical diagnosis of minor ischemic stroke (NIHSS ≤ 5) with persistent unilateral limb weakness or speech symptoms, defined as a score of ≥1 on either the language item or a single limb item of the NIHSS;

Pre-stroke mRS 0-1;

Disqualifiers

Planned or likely acute endovascular treatments before randomization;

NIHSS 1a > 2;

Known allergic to rhTNK-tPA;

History of intracranial hemorrhage;

Trial design

Design model

Parallel

Treatments tested in this trial

  • rhTNK-tPA

    Drug

    rhTNK-tPA 0.25mg/kg, the maximum dose does not exceed 25mg: 1 vial is dissolved in 3ml of sterile water for injection to prepare a medicinal solution with a concentration of 5.33mg/ml. Calculate the total amount of the drug according to the weight of participant, and the maximum dose shall not exceed 25 mg. It is administered as a single bolus intravenous injection, and the injection is completed within 5-10 seconds. Additionally, placebo oral aspirin and clopidogrel are given. Aspirin 100 mg and clopidogrel 300 mg are administered within 6 ± 2 hours following thrombolytic therapy.

  • Control group (Aspirin combined with clopidogrel)

    Drug

    Dual antiplatelets with aspirin 100mg and clopidogrel 300mg, plus placebo intravenous rhTNK-tPA. Placebo oral aspirin and clopidogrel are administered within 6 ± 2 hours following intravenous placebo.

Treatment groups

1,386 Participants
are divided into 2 treatment groups
Group A: Aspirin combined with clopidogrelPlacebo comparator 1 intervention
Group B: rhTNK-tPA (0.25 mg/kg)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90-day (± 7 days).

Modified Rankin Scale score, mRS 0-1

Time frame
at 90-day (± 7 days)

Secondary outcomes

1

Good functional outcome (mRS 0-2) at 90-day (± 7 days)

Time frame
at 90-day (± 7 days)
2

mRS score at 90-day (± 7 days)

shift analysis/ordinal distribution of mRS score at 90-day (±7 days)

Time frame
at 90-day (± 7 days)
3

COSMOS Scale 0-1 at 90-day (±7days)

Time frame
90-day± 7days
4

COSMOS scale at 90-day (±7 days)

shift analysis/ordinal distribution of COSMOS scale at 90-day (±7 days)

Time frame
90-day± 7days

Other outcomes

Sponsors and contacts

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

Beijing Tiantan Hospital

Lead sponsor

Source ClinicalTrials.gov
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