The Norwegian Tenecteplase Stroke Trial 2 (NOR-TEST 2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03854500|
Recruitment Status : Not yet recruiting
First Posted : February 26, 2019
Last Update Posted : August 21, 2019
Background: Alteplase is the only approved acute drug treatment in ischemic stroke and aims at dissolving arterial clots causing cerebral ischemia. The overall benefit of alteplase is substantial. However, there is considerable room for improvement as 2/3 of patients with large clots may not achieve reopening of the vessel and up to 40% of the patients remain severely disabled or die.
Tenecteplase, a modified tissue plasminogen activator, has been shown to be a more efficient and safer thrombolytic drug than alteplase in pre-clinical studies. Tenecteplase has replaced alteplase as thrombolytic treatment in myocardial infarction and may also be the drug of choice in ischemic stroke.
Tenecteplase and alteplase had a similar safety profile in the NOR-TEST trial and there were no differences in efficacy between the two treatment groups. However, a majority of patients had mild stroke which may be associated with a natural favorable prognosis.
In spite of these neutral results, tenecteplase has the potential to replace alteplase as the drug of choice, based on a better pharmacological profile and a simpler practical administration. There is, however, need for a higher number of patients to prove the efficacy and safety of tenecteplase.
Hypothesis: Tenecteplase 0.4 mg/kg has superior efficacy and similar safety profile compared with alteplase 0.9 mg/kg.
|Condition or disease||Intervention/treatment||Phase|
|Stroke, Acute Cerebrovascular Disorders Ischemic Stroke||Drug: Tenecteplase Drug: Alteplase||Phase 3|
Objectives: To compare efficacy and safety of tenecteplase 0.4 mg/kg (single bolus) vs. alteplase 0.9 mg/kg (10% bolus + 90% infusion/60 minutes) a) within 4½ hours after symptom onset; b) within 4½ hours after awakening with stroke symptoms, and c) as bridging therapy within 4½ hours before thrombectomy.
Study design: NOR-TEST-2 is a multi-centre PROBE (prospective randomised, open-label, blinded endpoint) trial, designed to establish superiority of tenecteplaseas compared with alteplase for consecutively admitted patients with acute ischaemic stroke treated within 4½ hours after symptom onset. Randomisation tenecteplase:alteplase is 1:1.
Endpoints: Primary endpoint is functional outcome (mRS 0-1) at 90 days (efficacy). Secondary endpoints include rates of cerebral hemorrhages on CT/MR at 24-48 hours and mortality (safety).
Patient recruitment: All patients admitted to hospital with acute ischaemic stroke eligible for standard iv thrombolysis with alteplase and with pre-stroke mRS<3 and NIHSS score of >5 on admission are potentially eligible for NOR-TEST-2.
Based on power calculations from NOR-TEST, NOR-TEST 2 aims at including 1342 patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1342 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, controlled multicenter study|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Randomised Trial of Tenecteplase vs. Alteplase in Acute Ischemic Stroke|
|Estimated Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||February 28, 2023|
|Estimated Study Completion Date :||May 28, 2023|
Active Comparator: Tenecteplase
0.4 mg/kg single bolus intravenously
Other Name: Metalyse
Active Comparator: Alteplase
0.9 mg/kg as 10% bolus + 90% infusion/60 minutes intravenously
Other Name: Actilyse
- Proportion of patients with favorable functional outcome [ Time Frame: 90 days ]Modified Rankin Scale 0-1 (favorable= 0-1, unfavorable 2-6)
- Symptomatic cerebral hemorrhage [ Time Frame: 24-48 hours ]Proportion of patients with haemorrhagic infarct/haematoma as defined by CT or MRI
- Any cerebral haemorrhage [ Time Frame: 24-48 hours ]Proportion of patients haemorrhagic infarct/haematoma as defined by CT or MRI
- Major neurological improvement [ Time Frame: 24 hours ]Proportion of patients >3 Points improvement by NIHSS score or NIHSS score 0 (NIHSS score range is 0-42)
- Functional handicap [ Time Frame: 90 days ]Ordinal shift analysis of modified Rankin scale (0-6)
- Mortality [ Time Frame: 90 days ]Proportion of patients who died
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03854500
|Contact: Christopher Elnan Kvistad, PhD||92422048||Echr@helse-bergen.no|
|Contact: Lars Thomassen, Prof, PhDfirstname.lastname@example.org|