Tissue Kallikrein Preventing the Restenosis After Stenting of Symptomatic MCA Atherosclerotic Stenosis
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|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
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): 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|