Low-dose Versus Standard Dose Alteplase in Acute Ischemic Stroke , 4 Monthes Prospective Study

NCT ID: NCT03847883

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 408 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-01
• Study Completion Date: 2019-02-14

Brief Summary

Cohort A Randomized Control trial of Ateplase 0.6, 0.75 and 0.9 mg/kg in 78 patients Cohort B single arm 0.9 mg/kg Ateplase in 330 patients Combined Cohort A and B evaluate different of death, intra-cerebral hemorrhage, numberof patient with mRS 0-1 at discharge and 3 months follow up, and other important stroke outcomes

Detailed Description

We conducted the prospective study to compare the low-dose and standard-dose rtPa and identify the important factors predicted stroke outcomes in acute stroke patient received intravenous rtPa. In Cohort A, During 2011-2012, 78 patients were randomly assigned to received intravenous rtPa 0.6 mg/kg , 0.75 mg/Kg, or 0.9 mg/Kg (1:1:1). After interim analysis during 2012-2017, in Cohort B, 330 patients were assigned to receive standard-dose rtPa 0.9 mg/kg. The good outcomes were defined as improvement of modified Rankin scale (mRS) by final score 0-1 or improvement > 4 points at discharge or 3 months follow up, absent of intracranial hemorrhage within 36 hours treatment, 90-day post-stroke survival , and short hospital length of stay.

Conditions

Acute Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

0.6 mg/kg Ateplase

Low dose 0.6 mg/kg Ateplase injection with in 4.5 Hr after onset of stroke (n = 26 in cohort A)

Group Type: ACTIVE_COMPARATOR

Intravenous Solution Ateplase

Intervention Type: DRUG

Infusion Low dose 0.6 or 0.75 or 0.9 mg/kg Ateplase injection iv bolus 10% of total dose and infusion 90% of total dose in1 hour , with in 4.5Hr after onset of stroke

0.75 mg/kg Ateplase

Low dose 0.75 mg/kg Ateplase injection with in 4.5 Hr after onset of stroke(n = 26 in cohort A)

Group Type: ACTIVE_COMPARATOR

Intravenous Solution Ateplase

Intervention Type: DRUG

Infusion Low dose 0.6 or 0.75 or 0.9 mg/kg Ateplase injection iv bolus 10% of total dose and infusion 90% of total dose in1 hour , with in 4.5Hr after onset of stroke

0.9 mg/kg Ateplase

Low dose 0.9 mg/kg Ateplase injection with in 4.5 Hr after onset of stroke(n = 26 in cohort A and n= 330 in Cohort B)

Group Type: ACTIVE_COMPARATOR

Intravenous Solution Ateplase

Intervention Type: DRUG

Infusion Low dose 0.6 or 0.75 or 0.9 mg/kg Ateplase injection iv bolus 10% of total dose and infusion 90% of total dose in1 hour , with in 4.5Hr after onset of stroke

Interventions

Intravenous Solution Ateplase

Infusion Low dose 0.6 or 0.75 or 0.9 mg/kg Ateplase injection iv bolus 10% of total dose and infusion 90% of total dose in1 hour , with in 4.5Hr after onset of stroke

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of Acute ischemic stroke

2. Age 18 to 80 years

3. Onset of stroke symptoms with in 4.5 hours before initiation of study-drug administration

4. Stroke symptoms present for at least 30 minutes with no significant improvement before treatment

Exclusion Criteria

1. patients with Intracranial hemorrhage

2. the symptoms of Time onset was unknown

3. Symptoms rapidly improving or only minor before start of infusion

4. Seizure at the onset of stroke

5. Stroke or serious head trauma within the previous 3 months

6. Administration of heparin within the 48 hours preceding the onset of stroke, with an activate

7. partial-thromboplastin time at presentation exceeding the upper limit of the normal range

8. Platelet count of less than 100,000 per cubic millimeter

9. Systole pressure greater than 185 mm Hg or diastole pressure greater than 110 mm Hg, or aggressive treatment intravenous medication) necessary to reduce blood pressure to these limits

10. Blood glucose less than 50 mg per deciliter or greater than 400 mg per deciliter

11. Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal

12. Oral anticoagulant treatment

13. Major surgery or severe trauma within the previous 3 months

14. Other major disorders associated with an increased risk of bleeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lumpang Hospital

UNKNOWN

Sponsor Role: collaborator

Department of Medical Services Ministry of Public Health of Thailand

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr Subsai Kongsaengdao

Associated Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assistant Professor Subsai Kongsaengdao

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

Rajavithi Lumphang 001 study

Identifier Type: -

Identifier Source: org_study_id