rhTNK-tPA for Acute Ischemic Stroke Under Simplified Imaging in the Extended Time Window

NCT07606807 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: PEARL-SIMPLIFIED
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Acute Ischemic Stroke

Keywords

Intravenous Thrombolysis; Extended Time Window; Simplified Imaging; Non-contrast CT; Tenecteplase

Outcome Measures

Primary Outcomes (1)

• Excellent functional outcome

  The proportion of mRS score 0-1 at 90 (±14) days.

  at 90 (±14) days

Secondary Outcomes (9)

• Ordinal distribution of mRS

  at 90 (±14) days

• Favorable functional outcome

  at 90 (±14) days

• Change in NIHSS Score at 24 (±12) hours

  at 24 (±12) hours

• Change in NIHSS Score at 7 (±1) days or discharge

  at 7 (±1) days or discharge

• Quality of life (EQ-5D-5L)

  at 90 (±14) days

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Intravenous tenecteplase

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

Control Arm

ACTIVE 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.

Intervention Arm

Standard medical treatment DRUG

Patients in the control arm will receive standard medical treatment.

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• Presumed acute ischemic stroke of the anterior circulation.
• Acute ischemic stroke symptom onset between 4.5 to 24 hours prior to enrollment; including wake-up stroke and unwitnessed stroke, onset time refers to 'last-known well time'.
• Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (inclusive).
• Limited early ischemic changes on non-contrast CT (NCCT).
• Written informed consent signed by patients or their legally authorized representatives.

You may not qualify if:

• Clearly demarcated hypodensity on non-contrast CT related to the current stroke, with limited anticipated clinical benefit as judged by the investigator.
• Intracranial or subarachnoid hemorrhage identified on baseline NCCT.
• Endovascular thrombectomy (EVT) planned at the time of randomization.
• Pre-stroke mRS≥2.
• Allergy to the test drug and its ingredients.
• Severe head trauma or ischemic stroke in the last 3 months.
• Intracranial or intraspinal surgery within 3 months before enrollment.
• Intracranial tumor or large-size aneurysm found before enrollment.
• Gastrointestinal or urinary system hemorrhage within the past 3 weeks.
• Active visceral bleeding.
• Aortic arch dissection confirmed by examination or medical history.
• Infective endocarditis confirmed by examination or medical history.
• Platelet count less than 100 × 109 /L.
• Patients received heparin or low-molecular-weighted heparin treatment within 24h before enrollment.
• Pregnant or lactating women.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, 510120, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tenecteplase

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tissue Plasminogen Activator; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Yamei Tang, MD, PhD

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinyuan Wang

CONTACT

86-18558992193; wangjy257@mail2.sysu.edu.cn

Xinguang Yang, MD, PhD

CONTACT

yangxinguang0926@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 26, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 26, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after the trial completion.
• Access Criteria: The IPD will be available from the Principal Investigator upon reasonable request 6 months after the trial completion.

Locations

CN (1)