NCT04588337Completed
INtravenous TNK for Acute isChemicsTroke in China
INtravenous TNK for Acute isChemicsTroke in China (INTACT-China): a Prospective, Multi-center, Registry Study
Source: ClinicalTrials.gov · Last updated 10 Apr 2024
Brief summary (registry, in English)
Acute ischemic stroke is the most common type of stroke, accounting for about 60%-80% of all stroke, with high incidence, high mortality, high disability rate, has become the first cause of death in China. At present, only ultra-early thrombolytic therapy, endovascular therapy and antiplatelet therapy have obtained evidence-based medical evidence in ischemic stroke treatment, but only thrombolytic therapy and endovascular therapy can improve the good prognosis of patients. Intravenous thrombolytic therapy within 4.5 hours after the onset of ischemic stroke symptoms has been shown to be effective, which is recommended in the guidelines. In most countries, alteplase (R-tPA) is the only drug approved for the treatment of acute ischemic stroke. Recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA) is a modified recombinant tissue-type plasminogen activator, with no procoagulant effect and a longer half life. In recent years, there are some studies on the comparison of therapeutic effects of TNK-tPA and RT-PA in patients with acute ischemic stroke, and TNK shows promising especially for large artery occlussion. At present, there are few reports on the application of rhTNK-tPA in Chinese stroke patients. The aim of this study is to evaluate the efficacy and safety of rhTNK-tPA in Chinese patients with ischemic stroke in a prospective, multicenter registration study.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1000 (actual)
- First submitted
- 3 Oct 2020
- Start date
- 6 Jan 2022
- Primary completion date
- 9 Apr 2024
- Lead sponsor
- General Hospital of Shenyang Military Region
- Diseases
- Stroke
- NCT number
- NCT04588337
What you commit to
- Study type: Observational
- Participants enrolled: 1000
- From 6 Jan 2022 to the primary completion date, 9 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intracranial or spinal cord surgery within 3 months;
- Major surgery within 1 month;
- Use of heparin or oral anticoagulation therapy within 48 hours;
Other illness
- Significant head trauma or stroke in the last 3 months;
- Subarachnoid hemorrhage;
- A history of intracranial hemorrhage or head injury or acute stroke within 3 months;
- Gastrointestinal or urinary tract hemorrhage within last 21 days;
- Uncontrolled hypertension (SYSTOLIC \>180 mmHg OR DIASTOLIC\>110 mmHg) ;
- Severe systemic disease with poor life expectancy (\<3 months); ;
- Allergic to research drug;
- Other conditions due to which investigators consider study participation inappropriate.
Lab values
- Thrombocytopenia (platelet count \<10×109/L);
- The Blood Glucose concentration \<50 mg/dl (2.7 mmol/L);
Other
- Severe neurologic deficits before onset (mRS ≥2) ;
- Intracranial tumors, arteriovenous malformations or aneurysms;
- Non-compressible arterial puncture within 7 days;
- Use of warfarin with an international normalised ratio \>1.7 or PT \>15 s;
- Within 3 months or participating in other clinical trials;
Who the study is looking for
- Age ≥18 ;
- The time from onset to treatment was less than 4.5 hours;
- Ischemic stroke confirmed by head CT or MRI;
- There are measurable neurological deficits;
- First onset or previous onset without obvious sequelae (Mrs ≤1 score) ;
- signed informed consent.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Neurology, General Hospital of Northern Theater Command Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.