Table 1.
Clinical trials comparing doses of tenecteplase
| Trial Name | Key Eligibility Criteria | Trial type | Enrollment | Primary Hypothesis / Outcome | Primary Outcome Results | Key Safety Outcomes | Date Published | Clinical Trial Number |
|---|---|---|---|---|---|---|---|---|
| Pilot Dose-Escalation Safety Study of Tenecteplase in Acute Ischemic Stroke | Time window: 0–3 hr NIHSS: NIHSS ≥ 1 Maximum age: none Vascular imaging: not reported Perfusion imaging: not reported Pre-stroke mRS: not specified |
Phase: 1/2, dose-escalation safety
study Randomized: No Blinded Treatment: No Blinded outcome assessment: Yes |
88 total enrollment 0.1 mg/kg tenecteplase (n=25) 0.2 mg/kg tenecteplase (n=25) 0.4 mg/kg tenecteplase (n=25) 0.5 mg/kg tenecteplase (n=13) |
Primary hypothesis: Tenecteplase is safe
for acute ischemic stroke ≤ 3 hr from onset at doses that may be
associated with improvement in clinical neurological
outcome Primary outcome: symptomatic ICH within 36 hr |
0.1, 0.2, 0.4 mg/kg no symptomatic
intracranial hemorrhages (ICHs) 0.5 mg/kg was closed after 2 of 13 patients (15%) had symptomatic ICH |
See primary outcome results | 2005 | n/a |
| TNK-tPA Evaluation for Minor Ischemic Stroke With Proven Occlusion (TEMPO-1) | Time window: 0–12 hr, ≤90 min
of CT/CTA NIHSS: < 6 Maximum age: none Vascular imaging: Acute occlusion relevant to symptoms Perfusion imaging: not reported Pre-stroke mRS: Barthel Index ≥ 90 or mRS ≤ 1 |
Phase: 2, safety,
feasibility Randomized: No, tiered Blinded treatment: No Blinded outcome assessment: No |
50 total enrollment 0.1 mg/kg tenecteplase (n=25) 0.2 mg/kg tenecteplase (n=25) |
Primary hypothesis: The treatment of minor
stroke with intracranial occlusion with tenecteplase is safe and
feasible. Primary outcome: Rate of expected serious adverse events |
No serious drug-related adverse events in
0.1 mg.kg group In the 0.25 mg/kg group, one symptomatic ICH |
Symptomatic ICH: 0.25 mg/kg group, 1/25
(4%) Mortality: 0.25 mg/kg group, 1/25 (4%) |
2015 | NCT01654445 |
| Determining the Optimal Dose of Tenecteplase Before Endovascular Therapy for Ischaemic Stroke (EXTEND-IA TNK Part 2) | Time window: 0–4 hr NIHSS: none Maximum age: none Vascular imaging: Arterial occlusion on CTA of the ICA, M1, M2, or basilar artery Perfusion imaging: not reported Pre-stroke mRS: ≤ 3 |
Phase: 2 Randomized: Yes Blinded treatment: No Blinded outcome assessment: Yes |
300 total enrollment 0.25 mg/kg tenecteplase (n=150) 0.4 mg/kg tenecteplase (n=150) |
Primary hypothesis: Superior recanalization
with 0.4 mg/kg vs 0.25 mg/kg Primary outcome: Substantial angiographic reperfusion (mTICI score = 2b/3) or absence of retrievable thrombus at initial angiogram |
Reperfusion: no difference, 0.40 mg/kg tenecteplase, 29/150 (19.3%), 0.25 mg/kg tenecteplase, 29/150 (19.3%), adjusted RR, 1.03, [0.66–1.61]; P = 0.89 | Symptomatic ICH: 0.40 mg/kg group - 7/150
(4.7%) and 0.25 mg/kg group - 2/150 (1.3%), unadjusted risk difference,
3.3% [−0.5%–7.2%]; RR = 3.50 [0.74–16.62]; P =
0.12 Mortality: 26/150 (17%) deaths in the 0.40 mg/kg group and 22/150 (15%) in the 0.25 mg/kg group (adjusted RR, 1.27 [0.77–2.11]; P = 0.35) |
2020 | NCT03340493 |