Condition category
Circulatory System
Date applied
14/10/2007
Date assigned
30/10/2007
Last edited
30/10/2007
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

Neurology Department
Beijing Tiantan Hospital
Tiantan Xili 6
Chongwen District
Beijing
100050
China
yongjunwang111@yahoo.com.cn

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5

Study information

Scientific title

Acronym

ITAIS- III

Study hypothesis

Whether the patients without occlusion or significant stenosis of the large vessels should receive thrombolysis had been focused on and questioned for a long time. However, there is still no large Randomised Controlled Trial (RCT) to prove if these patients can benefit from thrombolysis. The objective of this trail is to investigate:
1. For the selected acute ischemic stroke patients without large vessels occlusion or significant stenosis, whether the IntraVenous (IV) thrombolysis can improve the clinical outcome if the mismatch exists on CTP/Computed Tomography Angiography-Source Images (CTA-SI) scan in 3-9 hr time-window
2. For the selected acute ischemic stroke patients without large vessels occlusion or significant stenosis, whether the IV thrombolysis can improve the blood perfusion of brain if the mismatch exists on CT perfusion (CTP)/CTA-SI scan in 3-9 hr time-window
3. For the selected acute ischemic stroke patients without large vessels occlusion or significant stenosis, but the mismatch exists on CTP/CTA-SI scan in 3-9 hr time-window, whether the safety of IV thrombolysis is better than the NINDS trial which was in 3 hr window or implemented on the patients with large vessels occlusion or significant stenosis in 3-9 hr time-window.

Ethics approval

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

Study design

A prospective, multi-center, assessor-blind controlled trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Acute ischemic stroke

Intervention

Patients included were divided into recombinant tissue Plasminogen Activator (rt-PA) (0.9 mg/kg) intravenous thrombolysis group and regular treatment group according to the intention of doctors and patients.

Intervention type

Drug

Phase

Not Specified

Drug names

Recombinant tissue Plasminogen Activator (rt-PA)

Primary outcome measures

Proportion of participants who achieve the following:
1. Reperfusion improvement, assessed 24 to 48 hours post-treatment and defined as either greater than or equal to 30% reduction of Mean Transit Time (MTT) volume of abnormality
2. Good clinical outcome at 90 days defined as a modified Rankin score (mRS) of 0-1
3. Intracerebral haemorrhage within 24-36 h after thrombolysis

Secondary outcome measures

Proportion of participants who achieve the following:
1. mRS 0 to 2 at 90 days
2. Barthel Index (BI) score 75 to 100 at 90 days
3. NIHSS 4 points improvement or 0-1 at 2 hours after treatment
4. NIHSS 4 points improvement or 0-1 at 24 to 48 hours
5. NIHSS 4 points improvement or 0-1 at day 7

Overall trial start date

01/10/2007

Overall trial end date

01/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female or male inpatients
2. Age 18-80 years
3. Clinical diagnosis of ischaemic stroke
4. Onset of symptoms within 3-9 hours prior to initiation of thrombolysis treatment
5. Stroke symptoms present for at least 30 minutes and has not significantly improved before treatment
6. The National Institutes of Health Stroke Scale (NIHSS) score greater than or equal to 4
7. m-CT screening to be started within 8.5 hrs after stroke onset
8. Perfusion abnormality of CT scan >2cm in diameter involving hemisphere
9. CT Perfusion/CTA source image mismatch greater than or equal to 20%
10. CTA shows occlusion or significant stenosis of large vessels (Thrombolysis In Cerebral Ischemia [TICI] grade is 0 or 1)
11. Patients are willing to receive thrombolysis treatment and to give informed consent
12. Patients are willing and able to comply with the study protocol

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Evidence of IntraCranial Haemorrhage (ICH), brain tumors, vascular malformation, aneurysm, SubArachnoid Hemorrhage (SAH)
2. Major infarct involving greater than 1/3 of Middle Cerebral Artery (MCA) territory on the CTA-SI
3. Presenting obvious neurologic deficits because of past stroke (mRS >2)
4. Severe stroke as assessed clinically (e.g. The National Institute of Health Stroke Scale [NIHSS] >25) and/or by appropriate magnetic imaging techniques.
5. Seizure at onset of stroke
6. Prior stroke within the last 3 months
7. Patients with any history of prior stroke and concomitant diabetes
8. Administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory
9. Platelet count of below 100,000/mm3
10. 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 >185 mm Hg or diastolic blood pressure >=110 mm Hg on 3 repeated measures at least 10 minutes apart
11. Blood glucose <50 or >400 mg/dl
12. Known haemorrhagic diathesis within the last 6 months
13. Patients receiving oral anticoagulants e.g. warfarin sodium, and coagulant response time (INR) >1.5
14. Known history of or suspected intracranial haemorrhage including subarachnoid haemorrhage
15. Pregnancy or lactation
16. Any history of severe central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
17. Haemorrhagic retinopathy,e.g. in diabetes (vision disturbances may indicate haemorrhagic retinopathy)
18. Bacterial endocarditis, pericarditis
19. 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)
20. Acute pancreatitis
21. Documented ulcerative gastrointestinal disease during the last 3 months,
22. Oesophageal varices, arterial aneurysm, arterial/venous malformation
23. Neoplasm with increased bleeding risk
24. Severe liver disease including hepatic failure, cirrhosis, portal hypertension, oesophageal varices and active hepatitis
25. Major surgery or significant trauma in past 10 days
26. Known serious sensitivity to alteplase

Recruitment start date

01/10/2007

Recruitment end date

01/06/2010

Locations

Countries of recruitment

China

Trial participating centre

Neurology Department
Beijing
100050
China

Sponsor information

Organisation

Beijing Tiantan Hospital (China)

Sponsor details

Beijing Tiantan Hospital
Tiantan Xili 6
Chongwen District
Beijing
100050
China
yongjunwang111@yahoo.com.cn

Sponsor type

Hospital/treatment centre

Website

http://www.bjtth.com/

Funders

Funder type

Government

Funder name

The Ministry of Science and Technology and the Ministry of Health of the People's Republic of China - the key scientific research program of the 11th National Five-Year Planning of 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