Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03357133
Other study ID # 2017032
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received
Last updated
Start date December 16, 2017
Est. completion date August 31, 2020

Study information

Verified date September 2020
Source Capital Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

After intravenous thrombolysis, the overall recanalization rate is 46%, and recclusion after initial recanalization occurs in 14-34%. In the MR TEA, the investigators compared the effects of administration of tirofiban in acute ischemic stroke patients treated with intravenous alteplase thrombolysis with alteplase alone.


Recruitment information / eligibility

Status Terminated
Enrollment 30
Est. completion date August 31, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age =18

- Ischemic stroke symptom with onset =4.5 hours treated with IV rt-PA according with local guidelines.

- 6= NIHSS =20 before IV tPA, or NIHSS >20 but decrease = 8 after IV rt-PA.

- = 4 point total NIHSS or = 2 point in one NIHSS category during and after the IV rt-PA compared to immediately before worsening, an emergency CT scan should be performed to exclude intracranial hemorrhage

- Patients or their legally acceptable representative agreed to the treatment and signed the informed consent form

Exclusion Criteria:

- Patients whom the treating physician is planning to treat with mechanical thrombectomy or other endovascular procedure (e.g. Intra-arterial thrombolysis) according with local guidelines.

- Patients had used antiplatelet therapy in the past 5 days before the stroke.

- Patients had used anticoagulant therapy in the past 5 days before the stroke.

- Scheduled for surgery or interventional treatment requiring study drug cessation.

- CT scan finding of hypoattenuation involving =1/3 of the MCA territory.

- Any evidence of clinically significant bleeding ,or known coagulopathy.

- Renal insufficiency (creatinine clearance rate <30ml/min)

- Hepatic dysfunction (ALT >2 folds of Upper limit of normal value or AST>2 folds of Upper limit of normal value).

- Pre-existing disability with = mRS 2.

- Known allergic to tirofiban or other glycoprotein IIb/IIIa antagonist.

- Severe non-cerebrovascular disease with life expectancy <3 months

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tirofiban
Tirofiban Injection after the alteplase intravenous thrombolysis
Alteplase
Only alteplase intravenous thrombolysis

Locations

Country Name City State
China Xuanwu Hospital, Capital Medical University Beijing Beijing
China The Central Hospital of Luohe City Luohe Henan
China Luzhou People's Hospital Luzhou Sichuan
China Suzhou Municipal Hoapital Suzhou An Hui
China Xiangtan Central Hospital Xiangtan
China The Fifth Affiliated Hospital of Zhengzhou University Zhengzhou
China The First Affiliated Hospital of Zhengzhou University Zhengzhou

Sponsors (1)

Lead Sponsor Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Symptomatic intracranial hemorrhage 7 days or discharge
Other Severe systemic bleeding 7 days or discharge
Other Stroke-related death 90 days
Other Death form any cause 90 days
Primary The rate of favorable outcome favorable outcome was defined as a score of 0, or 1 on the modified Rankin scale 90 days
Secondary mRS =2 90 days
Secondary NIHSS score 7 days
Secondary Deterioration after improvement 24 hours
Secondary Final infarct size 24 hours
See also
  Status Clinical Trial Phase
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Recruiting NCT05518305 - Platelet Expression of FcγRIIa and Arterial Hemodynamics to Predict Recurrent Stroke in Intracranial Atherosclerosis
Recruiting NCT06029959 - Stroke and CPAP Outcome Study 3 N/A
Recruiting NCT03728738 - Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke Phase 3
Terminated NCT03396419 - IMPACT- 24col Collateral Blood Flow Assessment Following SPG Stimulation in Acute Ischemic Stroke (ImpACT-24B Sub-Study)
Recruiting NCT05065216 - Treatment of Acute Ischemic Stroke (ReMEDy2 Trial) Phase 2/Phase 3
Recruiting NCT04897334 - Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke N/A
Not yet recruiting NCT06032819 - Differentiating Between Brain Hemorrhage and Contrast
Not yet recruiting NCT06026696 - Cohort of Neurovascular Diseases Treated in the Acute Phase and Followed at Lariboisière
Not yet recruiting NCT05983757 - Combined Thrombectomy for Distal MediUm Vessel Occlusion StroKe N/A
Recruiting NCT02910180 - Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders
Completed NCT02922452 - A Study to Evaluate the Effect of Diltiazem on the Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects Phase 1
Withdrawn NCT01866189 - Identification of Hypoxic Brain Tissues by F-MISO PET in Acute Ischemic Stroke N/A
Completed NCT03554642 - Walkbot Robotic Training for Improvement in Gait Phase 3
Recruiting NCT03041753 - Reperfusion Injury After Stroke Study N/A
Completed NCT02549846 - AdminiStration of Statin On Acute Ischemic stRoke patienT Trial Phase 4
Completed NCT01678534 - Reparative Therapy in Acute Ischemic Stroke With Allogenic Mesenchymal Stem Cells From Adipose Tissue, Safety Assessment, a Randomised, Double Blind Placebo Controlled Single Center Pilot Clinical Trial Phase 2
Completed NCT02610803 - Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke N/A