Tissue Kallikrein Preventing the Restenosis After Stenting of Symptomatic MCA Atherosclerotic Stenosis
|ClinicalTrials.gov Identifier: NCT01558245|
Recruitment Status : Unknown
Verified September 2013 by Zhang Renliang, Jinling Hospital, China.
Recruitment status was: Recruiting
First Posted : March 20, 2012
Last Update Posted : September 12, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cerebrovascular Disease||Drug: tissue kallikrein||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Tissue Kallikrein Preventing the Restenosis After Stenting of Symptomatic MCA Atherosclerotic Stenosis|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
Experimental: Tissue kallikrein group
Patients in this group will be prescribed with intravenous infusion of TK (0.15 PNAU/d, dissolved in 100ml saline) for 7 days after stenting and then oral administration of pancreatic kallikrein enteric-coated tablet (240U, 3/d) to the end of study. As the foundation treatment, all the enrolled patients will receive aspirin (100 mg/d), clopidogrel (75 mg/d), and atorvastatin (20 mg/d) for the first 6 months and continue with the combination of aspirin and atorvastatin at the previous dosage.
Drug: tissue kallikrein
Human urinary kallidinogenase can transform kininogen to bradykinin (kinin) and vasodilatory factors (kallidin)
Other Name: Human urinary kallidinogenase (HUK)
No Intervention: Control group
Patients in control group will receive foundation treatment, including aspirin (100 mg/d), clopidogrel (75 mg/d), and atorvastatin (20 mg/d) for the first 6 months and continue with the combination of aspirin and atorvastatin at the previous dosage.
- Target lesion failure [ Time Frame: 12 months ]Patients will be evaluated at 1 month, 6 months, and 12 months after the stenting. The primary outcomes are the asymptomatic or symptomatic in-stent restenosis ≥ 50% (affirmed by digital subtraction angiography at 6 and 12 months), new stroke (ischemic and hemorrhagic) or aggravation of the previous ischemic stroke ipsilateral to the severe stenotic artery.
- Clinical endpoint [ Time Frame: 12 months ]Stroke of other artery territories, myocardial infarction and vascular death will be conducted in-hospital and planned at 1 month, 6 months, and 12 months.
- Laboratory data [ Time Frame: 12 months ]Laboratory data including bradykinin (BK), TK, platelet inhibitory rate, cGMP, cAMP, hs-CRP, TNF-α, IL-6, LDL-Ch and HDL-Ch will be recorded
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558245
|Contact: Renliang Zhang, MD||+ email@example.com|
|Department of Neurology, Jinling Hospital, Nanjing University School of Medicine||Recruiting|
|Nanjing, Jiangsu, China|
|Contact: Renliang Zhang, MD + 86-25-8480386 firstname.lastname@example.org|
|Principal Investigator:||Renliang Zhang, MD||Department of Neurology, Jinling Hospital, Nanjing University School of Medicine|