NCT07092709

Tenecteplase for Intravenous Stroke Thrombolysis in Recent DOAC Users

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 912 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of intravenous tenecteplase thrombolysis in AIS patients with recent DOACs intake 48 hours prior to enrollment. The primary outcome is the proportion of patients with a 90-day modified Rankin scale (mRS) of 0-1. Study intervention: (1) Participants in the intervention group will receive tenecteplase 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. (2) Participants in the control group will receive matched intravenous placebo in the same approach. All participants will receive standard medical treatment. A total of 912 participants are anticipated to be recruited for this study, with 456 participants in each group (1:1 ratio).

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)	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.
DRUG	Placebo	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.

Timeline

• Start date: 2025-08-14
• Primary completion: 2028-09-01
• Completion: 2028-12-31
• First posted: 2025-07-30
• Last updated: 2025-12-16

Locations

1 site across 1 country: China