Tenecteplase REperfusion in Acute Ischemic sTroke Registry（TREAT）

NCT05724342 | Unknown

• 1 other identifier: KY2022-236-02
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study was to establish tenecteplase thrombolysis database and to investigate the effectiveness and safety of rhTNK-tPA in acute ischemic stroke patients.

Conditions

Stroke, Ischemic

Keywords

thrombolysis; tenecteplase

Outcome Measures

Primary Outcomes (1)

• Excellent functional outcome at 90 days

  proportion of mRS score 0-1 at 3 months. The modified Rankin Scale (mRS) has a minimum value of 0 and maximum value of 6. Higher value indicated worse functional outcome

  3 months after thrombolysis

Secondary Outcomes (7)

• Favorable functional outcome

  3 months after thrombolysis

• Walk independence

  3 months after thrombolysis

• Ordinal distribution of mRS at 90 days

  3 months after thrombolysis

• Neurological improvement at 24 hours

  24 hours after thrombolysis

• NIHSS score at discharge

  5-7days after thrombolysis or at discharge

Other Outcomes (3)

• Symptomatic intracerebral hemorrhage at 36 hours

  36 hours after thrombolysis

• Hemorrhage in other parts

  36 hours after thrombolysis

• Mortality at 90 days

  90 days after thrombolysis

Study Arms (1)

rhTNK-tPA Thrombolysis

Drug: rhTNK-tPA Thrombolysis

Interventions

rhTNK-tPA Thrombolysis DRUG

rhTNK-tPA Thrombolysis

rhTNK-tPA Thrombolysis

Eligibility Criteria

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

Study Population

acute ischemic stroke patients treated with rhTNK-tPA and derivatives in China.

You may qualify if:

• Older than 18 years;
• Diagnosed as acute ischemic stroke；
• Time intervals ≤ 4.5 hours from stroke onset to thrombolysis with TNK(Perfusion imaging completed including CTA+CTP or MRA+PWI+DWI before thrombolysis if the time intervals from stroke onset to thrombolysis was ≥4.5 hours)；
• Thrombolysis with rhTNK-tPA and derivatives.

You may not qualify if:

• Unlikely to adhere to the study protocol or follow-up ( life expectancy ≤ 3 months)；
• Already participated in other interventional trials.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• National Natural Science Foundation of China: collaborator
• Beijing Municipal Science & Technology Commission: collaborator
• Beijing Municipal Administration of Hospitals: collaborator

Study Sites (1)

Yunyun Xiong

Beijing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum sample

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Yunyun Xiong, MD, PhD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunyun Xiong, MD, PhD

CONTACT

00861059975213; xiongyunyun@bjtth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology and Stroke Center

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 13, 2023
• Study Start: February 15, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

CN (1)