Tenecteplase for Thrombolysis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
ThrombolysisTenecteplase - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effectiveness of a clot-busting drug to a placebo in people who have had a stroke. All participants will also receive the standard care for a stroke.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Day 30 and Day 90

Day 1
Proportion of patients with angiographic reperfusion
Day 2
Number of patients with symptomatic intracranial hemorrhage (sICH a)
Proportion of patients with recanalization at 24 hours post-randomization
Proportion of patients with reperfusion at 24 hours post-randomization
Day 3
Proportion of patients with parenchymal hematoma type 2 (PH2) at the 72-96 hour visit
Day 90
Mortality rate up to Day 30 and Day 90
Day 90
Median NIHSS score
Ordinal modified Rankin scale (mRS) score
Proportion of patients with a Barthel Index (BI) score >=95
Proportion of patients with functional independence
Proportion of patients with good recovery based on the Glasgow Outcome Scale (GOS) at Day 90
Day 90
Incidence and severity of adverse events

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Tenecteplase
2%Nausea
2%Headache
1%Muscle Spasms
1%Hypertension
1%Pruritus
1%Haemodynamic Instability
1%Hypotension
This histogram enumerates side effects from a completed 2008 Phase 3 trial (NCT00396253) in the Tenecteplase ARM group. Side effects include: Nausea with 2%, Headache with 2%, Muscle Spasms with 1%, Hypertension with 1%, Pruritus with 1%.

Trial Design

2 Treatment Groups

Tenecteplase
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

456 Total Participants · 2 Treatment Groups

Primary Treatment: Tenecteplase · Has Placebo Group · Phase 3

Tenecteplase
Biological
Experimental Group · 1 Intervention: Tenecteplase · Intervention Types: Biological
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenecteplase
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 30 and day 90

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,497 Previous Clinical Trials
564,203 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
A patient's neuroimaging (ICA or M1, M2 occlusion by magnetic resonance angiography [MRA] or computed tomography angiography [CTA]) will be assessed for a target mismatch profile on CT perfusion or MR perfusion (ischemic core volume <70 mL, mismatch ratio is >=1.8 and mismatch volume is >= 15 mL).
The mismatch volume is calculated using an FDA-approved image analysis program in real time, based on the size of the core lesion volume and the volume of lesion with Tmax>6s
If the MRI reveals that the patient has a technically inadequate Magnetic Resonance Perfusion (MRP), then the doctor will order an ICA or M1, M2 occlusion by MRA (or CTA, if MRA is technically inadequate and a CTA was performed within 60 minutes prior to the MRI) and a DWI lesion volume <= 25mL for an M1 or ICA occlusion and <=15mL for an M2 occlusion.
The patient has an AIS and experiences signs and symptoms within 4.5 to 24 hours that are consistent with the diagnosis of an acute anterior circulation ischemic stroke
If CTP is technically inadequate, a patient can be screened with MRI to see if they meet the neuroimaging criteria
The patient or legally authorized representative has signed the Informed Consent Form.
to tirofiban or placebo The patient has a baseline NIHSS of >=5 and that remains >=5 immediately prior to randomization to tirofiban or placebo.
The individual was functionally independent (mRS 0-2) prior to stroke onset.
If the patient has a CTA that is technically inadequate, meaning that the maximal T-time is greater than 6 seconds, and there is evidence of an ICA or M1, M2 occlusion, then the target mismatch profile should be evaluated