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

Acute Stroke Clinical Trial

Official title:

Low-dose Versus Standard-dose Ateplase in Acute Ischemic Stroke ; A 4 Months Prospective Randomized Control Pilot Follow by Single Arm Standard Dose Ateplase Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03847883
• Other study ID #: Rajavithi Lumphang 001 study
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2011
• Est. completion date: February 14, 2019

Study information

• Verified date: February 2019
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: February 14, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Thailand	Assistant Professor Subsai Kongsaengdao	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Rajavithi Hospital	Lumpang Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death in 36 hours	Number of patient die in 36 hours	0-36 hours
Primary	Death in 3 months	Number of patient die in 3 months	0-3 months
Primary	Death in 4 months	Number of patient die in 4 months	0-4 months
Primary	Total number of patients with mRS 0-1 at discharged	Number of patients with mRS 0-1 at discharge 1day to 3 months interval	1day to <3 months
Primary	Total number of patients with mRS 0-1 at 3 months	Number of patients with mRS 0-1 at 3 months	At 3 months
Primary	Number of patients with All intra-cerebral hemorrhage (ICH) at 36 hours	Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH	0- 36 hours
Primary	Number of patients with All intra-cerebral hemorrhage (ICH) at 3 months	Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH	0-3 months
Primary	Number of patients with All Intra-cerebral hemorrhage (ICH) at 4months	Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH	0-4 months
Primary	Number of patients with Symptomatic Intra-cerebral hemorrhage (ICH) at 36 hours	Total Number of patients with Symptomatic ICH need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration	0-36 hours
Primary	Number of patients with Symptomatic Intra-cerebral hemorrhage (ICH) at 4 months	Total Number of patients with Symptomatic ICH need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration	0-4 months
Primary	Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 36 hours	Total Number of patients with Asymptomatic ICH wich no need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration	0-36 hours
Primary	Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 3 months	Total Number of patients with Asymptomatic ICH wich no need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration	0-3 months
Primary	Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 4 months	Total Number of patients with Asymptomatic ICH wich no need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration	0-4 months
Secondary	Good stroke outcomes	Total number of patients with "good outcomes" were defined as number of patients with this any one item criteria; improvement of modified Rankin scale (mRS) by final score 0-1; mRS improvement > 4 points at discharge or 3 months follow up, And must full fill all of this criteria; 1) absent of intracranial hemorrhage within 36 hours treatment and 2) survive at 90-day post-stroke ,and 3) short hospital length of stay less than 7 days	0-4 months
Secondary	Improved mRS at discharge	Number of patients with improve mRS after treatment at least 1 Score	(At discharge) 1 day to 3 months
Secondary	Improved mRS 3 months	Number of patients with improve mRS after treatment at least 1 Score	At 3 months
Secondary	Number of patienta with Length of hospital stay (LOS) less than 7 days Days	Number of patients with LOS < 7 days ( patients must survive )	1- 7 days
Secondary	All complications	Number of patients with stroke complications after treatment	0-4 months