CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 750 target
Drug / intervention
Tenecteplase (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg) +1 moredrug
Likely dose
Tenecteplase (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07606807
NCT07606807Phase 3RecruitingOn Track
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rhTNK-tPA for Acute Ischemic Stroke Under Simplified Imaging in the Extended Time Window: A Multicenter, Prospective, Randomized Controlled, Open-label, Blinded-Endpoint Trial

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University·interventional·Posted May 26, 2026·Updated Jun 15, 2026

In Brief

A Phase 3 clinical trial evaluating Tenecteplase (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg) and Standard medical treatment for Acute Ischemic Stroke. Currently recruiting, targeting 750 participants across 1 site.

Detailed Summary

The PEARL-SIMPLIFIED trial is a multicenter, prospective, randomized controlled, open-label, blinded-endpoint study. It aims to evaluate the efficacy and safety of intravenous tenecteplase (TNK) in patients with acute ischemic stroke (AIS) presenting in the extended 4.5-24 hour window, using a simplified imaging selection strategy based solely on non-contrast CT (NCCT).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Ischemic Stroke
CountriesChina
Collaborators--

Timeline

Phase 3Recruiting
202720282029
First PostedMay 26, 2026
Enrollment StartAug 1, 2026
Primary CompletionDec 1, 2028
TodayJul 1, 2026
Enrollment to primary: 2.3 yearsPosted 1 month agoPrimary completion in 2.4 years

Arms & Interventions

Intervention Armexperimental

Intravenous tenecteplase

Drug: Tenecteplase (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg)
Control Armactive_comparator

Standard medical treatment

Drug: Standard medical treatment

Interventions

Tenecteplase (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg)drug

Patients randomized to the intervention arm will receive tenecteplase via a single intravenous bolus (0.25 mg/kg; maximum dose 25 mg), administered immediately following randomization.

Standard medical treatmentdrug

Patients in the control arm will receive standard medical treatment.