Condition category
Circulatory System
Date applied
03/08/2007
Date assigned
17/08/2007
Last edited
17/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Yongjun Wang

ORCID ID

Contact details

Beijing Tiantan Hospital
No.6 Tiantan Xili
Chongwen District
Beijing
100050
China
+86 (0)10 6709 6699
yongjunwang111@yahoo.com.cn

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5

Study information

Scientific title

Acronym

TRAIS-CHINA

Study hypothesis

1. To evaluate the clinical status of recombinant tissue Plasminogen Activator (rt-PA) thrombolysis in acute ischaemic stroke (within a three-hour time-window) in China
2. To assess whether the safety and efficacy of thrombolysis in acute ischaemic stroke are equivalent in the settings of randomised controlled trials and during implementation into clinical routine in China

Ethics approval

Approval gained from the Beijing Tiantan Hospital Capital Medical University Ethics Board on October 10, 2006.

Study design

An open, prospective, multicentre, non-randomised observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Acute ischaemic stroke

Intervention

All patients will be given intravenous (i.v.) rt-PA 0.9 mg/kg body weight (bw), 10% bolus, one-hour infusion, as part of their treatment. Patients will then be observed and followed-up for three months.

Intervention type

Drug

Phase

Not Specified

Drug names

Recombinant tissue Plasminogen Activator (rt-PA)

Primary outcome measures

1. Symptomatic intracerebral haemorrhage within 24 to 36 hours
2. Death (modified Rankin Scale [mRS] = 6) within three months

Secondary outcome measures

Independence for the activities of daily living at three months defined as a modified Rankin score (mRS) of 0 to 2.

Overall trial start date

01/04/2007

Overall trial end date

01/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female or male inpatients
2. Age 18 to 80 years
3. Clinical diagnosis of ischaemic stroke
4. Onset of symptoms within three hours prior to initiation of thrombolysis treatment
5. Stroke symptoms present for at least 30 minutes and has not significantly improved before treatment
6. Patients are willing to receive thrombolysis treatment and to give informed consent
7. Patients are willing and able to comply with the study protocol

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

330

Participant exclusion criteria

1. Evidence of Intracranial Haemorrhage (ICH), brain tumours, vascular malformation, aneurysm, Subarachnoid Haemorrhage (SAH) or major early infarct signs involving greater than 1/3 of Middle Cerebral Artery (MCA) territory on the Computed Tomography (CT)-scan
2. Severe stroke as assessed clinically (e.g. National Institutes of Health Stroke Scale [NIHSS] greater than 25) and/or by appropriate imaging techniques
3. Seizure at onset of stroke
4. Prior stroke within the last three months
5. Patients with any history of prior stroke and concomitant diabetes
6. Administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory
7. Platelet count of below 100,000/mm^3
8. Uncompensated hypertension at study entry or hypertension requiring aggressive treatment to reduce blood pressure to nonhypertensive limits. Uncompensated hypertension is defined as systolic blood pressure greater than 185 mmHg or diastolic blood pressure greater than or equal to 110 mmHg on three repeated measures at least 10 minutes apart
9. Blood glucose less than 50 or greater than 400 mg/dl
10. Known haemorrhagic diathesis within the last six months
11. Patients receiving oral anticoagulants, e.g., warfarin sodium, and International Normalised Ratio (INR) greater than 1.5
12. Known history of or suspected intracranial haemorrhage including subarachnoid haemorrhage
13. Pregnancy or lactation
14. Any history of severe central nervous system damage (i.e., neoplasm, aneurysm, intracranial or spinal surgery)
15. Haemorrhagic retinopathy, e.g., in diabetes (vision disturbances may indicate haemorrhagic retinopathy)
16. Bacterial endocarditis, pericarditis
17. Prolonged traumatic external heart massage, or recent (less than 10 days) obstetrical delivery or recent puncture of a non-compressible blood-vessel (e.g. subclavian or jugular vein puncture)
18. Acute pancreatitis
19. Documented ulcerative gastrointestinal disease during the last three months
20. Oesophageal varices, arterial-aneurysm, arterial/venous malformation
21. Neoplasm with increased bleeding risk
22. Severe liver disease, including hepatic failure, cirrhosis, portal hypertension oesophageal varices) and active hepatitis
23. Major surgery or significant trauma in past 10 days
24. Known serious sensitivity to Alteplase

Recruitment start date

01/04/2007

Recruitment end date

01/06/2010

Locations

Countries of recruitment

China

Trial participating centre

Beijing Tiantan Hospital
Beijing
100050
China

Sponsor information

Organisation

Beijing Tiantan Hospital (China)

Sponsor details

No.6 Tiantan Xili
Chongwen District
Beijing
100050
China
+86 (0)10 6709 6699
yongjunwang111@yahoo.com.cn

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

The Key Scientific Research Program of the 11th National Five-Year Planning of China (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes