CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 912 target
Drug / intervention
Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) +1 moredrug
Likely dose
Tenecteplase (TNK) (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/NCT07092709
NCT07092709Phase 3RecruitingOn TrackUpdated 6mo ago
CompareCT.gov

Tenecteplase for Intravenous Stroke Thrombolysis in Recent DOAC Users (PEARL-DOAC): A Multicenter, Prospective, Randomized, Double-blinded, Placebo-controlled Trial

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University·interventional·Posted Jul 30, 2025·Updated Dec 16, 2025

In Brief

A Phase 3 clinical trial evaluating Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) and Placebo for Acute Ischemic Stroke. Currently recruiting, targeting 912 participants across 1 site.

Detailed Summary

An investigator-initiated, multicenter, randomized, placebo-controlled, double-blind trial to determine the efficacy and safety of intravenous tenecteplase thrombolysis in acute ischemic stroke (AIS) patients with recent direct oral anticoagulants (DOACs) intake in improving the 90-day functional outcome.

Study Details

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

Timeline

Phase 3Recruiting
2026202720282029
First PostedJul 30, 2025
Enrollment StartAug 14, 2025
Primary CompletionSep 1, 2028
Study CompletionDec 31, 2028
TodayJul 1, 2026
Enrollment to primary: 3.0 yearsPosted 11 months agoPrimary completion in 2.2 years

Interventions

Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)drug

Tenecteplase is administered as a single intravenous bolus at a dose of 0.25 mg/kg, with a maximum of 25 mg, administered as soon as possible after the randomization, and within 24 hours of stroke onset.

Placebodrug

Matched placebo is administered as a single intravenous bolus at a dose of 0.25 mg/kg, with a maximum of 25 mg, administered as soon as possible after the randomization, and within 24 hours of stroke onset.