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RecruitingNCT05624190ANGEL-TNKUpdated Mar 19, 2024

Intra-arterial Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) Thrombolysis for Acute Large Vascular Occlusion After Successful Mechanical Thrombectomy Recanalization

A Phase 4 interventional study of Recombinant Human tenecteplase Tissue-type Plasminogen Activator (rhTNK-tPA) and Best Medical Management in Ischemic Stroke, Acute, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-19.

Sponsored by Beijing Tiantan Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Started Feb 2023; still recruiting 3 years 7 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
256
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this clinical trial is to evaluate whether intra-arterial (IA) rhTNK-tPA thrombolysis can improve neurological outcomes in acute large vessel occlusion patients after successful mechanical thrombectomy (MT) recanalization between 4.5- 24 hours from symptom onset. Participants enrolled will be randomly assigned to study or control arm with a 1:1ratio. Study group will receive IA rhTNK-tPA thrombolysis (0.125 mg/kg, Max 12.5mg) plus best medical management, and control receive best medical management alone.

02

Conditions studied

  • Ischemic Stroke, Acute
03

In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.

This study's planned enrollment of 256 is above the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Clinical Inclusion Criteria:

  1. Age >18 years;
  2. NIHSS ≥2;
  3. Onset of symptoms to baseline CT imaging time: 4.5 to 24 hours, including wake-up stroke and unwitnessed stroke; Time of onset of symptoms is defined as "last known well" (LKW);
  4. Pre-stroke mRS score 0-1;
  5. Signed informed consent from patient or their health care proxy.

Neuroimaging Inclusion Criteria:

  1. CTA/MRA proven intracranial artery occlusion: Intracranial Internal Carotid Artery (ICA)、M1 of Middle cerebral artery (MCA)、dominant M2 of MCA;
  2. ASPECTS ≥6 on non-contrast CT (NCCT) scan or DWI MRI;
  3. CT perfusion or MR perfusion: ischemic infarct core \<70ml, mismatch ratio≥1.2, mismatch volume ≥15ml;
  4. Treated with MT resulting in an eTICI score 2b50-3 at end of the procedure. Patients with an eTICI score 2b50-3 on the diagnostic cerebral angiography before the onset of MT are also eligible for the study.

Exclusion criteria

Exclusion Criteria:

Clinical Exclusion Criteria:

  1. IV thrombolysis used on admission;
  2. Contraindications to intravenous thrombolysis;
  3. Balloon angioplasty, permanent stenting and other situations during the endovascular procedure that require antiplatelet therapy or anticoagulant within the first 24h;
  4. IV heparin (heparinized saline allowed);
  5. Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test;
  6. Brain tumor (with mass effect);
  7. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
  8. Known coagulopathy, INR>1.7 or use of novel anticoagulants \< 48h from symptom onset
  9. Platelets \< 50*109/L;
  10. Suspicion of septic emboli or endocarditis
  11. Renal Failure as defined by a serum creatinine > 2.5 mg/dl (or 220μmol/l) or glomerular Filtration Rate [GFR] \< 30ml/min;
  12. Patient who requires hemodialysis or peritoneal dialysis, or who has a contraindication to angiogram for whatever reason;
  13. Suspicion of aortic dissection;
  14. Parenchymal organ surgery and biopsy were performed in the past one month;
  15. Any active bleeding or recent bleeding (gastrointestinal bleeding, urinary bleeding, etc.) in the past 1 month;
  16. History of life-threatening allergy (more than rash) to contrast medium;
  17. SBP >185 mmHg or DBP >110 mmHg refractory to treatment;
  18. Serious, advanced, terminal illness with anticipated life expectancy \< 6 months;
  19. Participation in another randomized clinical trial that could confound the evaluation of the study;
  20. Other circumstances that the investigator considers inappropriate for participation or may pose a significant risk to patients (e.g. inability to understand and/or comply with study procedures and/or follow-up due to mental disorders, cognitive or mood disorders).

Specific Neuroimaging Exclusion Criteria

  1. Midline shift or herniation, mass effect with effacement of the ventricles
  2. Evidence of acute intracranial hemorrhage on CT/MRI
  3. Acute bilateral strokes or multiple intracranial vessel occlusions
  4. Isolated extracranial ICA occlusion or tandem carotid / MCA occlusion
  5. Dissection of occluded artery on DSA after thrombectomy
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
256 participants (estimated)

Study arms

  • Experimental
    TNK group

    Patients of this group will receive IA rhTNK-tPA plus Best Medical Management (BMM) after successful mechanical thrombectomy (MT) recanalization

    Drug: Recombinant Human tenecteplase Tissue-type Plasminogen Activator (rhTNK-tPA) · Other: Best Medical Management

  • Active comparator
    control group

    Patients of this group will receive Best Medical Management (BMM) alone after successful mechanical thrombectomy (MT) recanalization

    Other: Best Medical Management

Interventions

  • DrugRecombinant Human tenecteplase Tissue-type Plasminogen Activator (rhTNK-tPA)

    The administration of rhTNK-tPA will be infused constant and slowly over 15min (0.125 mg/kg, Max 12.5mg) through a microcatheter.

    Also known as: IA rhTNK-tPA

  • OtherBest Medical Management

    Best Medical Management

06

What researchers measure

Primary outcomes

  1. Rate of excellent outcome

    Rate of 90 (±7) day modified Rankin scale (mRS) 0-1

    Time frame: 90±7 days after randomization

Secondary outcomes

  1. Rate of sICH (Heidelberg Bleeding Classification)

    Rate of sICH (Heidelberg Bleeding Classification)

    Time frame: within 48 hours after randomization

  2. Volume of Tmax>6s

    Time frame: 24 hours (±12 hours) after randomization

  3. Infarct core volume change from baseline

    Infarct core volume change from baseline, assessed with NCCT at 7 days (±1 day) after randomization/at discharge or with MRI at 36 hours (±12 hours)

    Time frame: 7 days (±1 day) after randomization/at discharge or at 36 hours (±12 hours) after randomization

  4. mRS (shift analysis)

    mRS (shift analysis)

    Time frame: 90 days (±7 days) after randomization

  5. Rate of good outcome

    Rate of mRS 0-2

    Time frame: 90 days (±7 days) after randomization

  6. Rate of mRS 0-3

    Rate of mRS 0-3

    Time frame: 90 days (±7 days) after randomization

  7. NIHSS 0-1 or decrease ≥10 from baseline NIHSS

    NIHSS 0-1 or decrease ≥10 from baseline NIHSS

    Time frame: 36 hours (±12hours) after randomization

  8. EQ-5D-5L score

    EQ-5D-5L score

    Time frame: 90 days (±7 days) after randomization

  9. All-caused mortality

    All-caused mortality

    Time frame: 90 days (±7 days) after randomization

  10. Rate of any intracranial hemorrhage (Heidelberg Bleeding Classification)

    Rate of any intracranial hemorrhage (Heidelberg Bleeding Classification)

    Time frame: within 48 hours after randomization

07

Study locations

1 of 1 sites recruiting
  • Beijing Tiantan Hospital, Capital Medical University
    Beijing, Beijing 100070, China
    • Zhongrong Miao · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05624190
Lead sponsor
Beijing Tiantan Hospital
Responsible party
Zhongrong Miao (Director of Department of interventional neurology, Beijing Tiantan Hospital) — Principal investigator
First posted
Nov 22, 2022
Start date
Feb 16, 2023
Primary completion
Jul 2024 (estimated)
Completion
Jul 2024 (estimated)
Last update
Mar 19, 2024

Study contacts

Xiaochuan Huo, Dr.
Contact
huoxiaochuan@126.com
+8613716292262

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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