NDLI: Comparison of antiplatelet effect and safety of clopidogrel napadisilate with clopidogrel bisulfate in stroke patients: multicenter, randomized, open-label, phase 4, non-inferiority clinical trial.

Please wait, while we are loading the content...

Perioperative blood loss and gastrointestinal tolerability of etoricoxib and diclofenac in total hip arthroplasty (ETO-DIC study): a single-center, prospective double-blinded randomized controlled trial.

Adherence to NICE guidance on glucagon-like peptide-1 receptor agonists among patients with type 2 diabetes mellitus: an evaluation using the Clinical Practice Research Datalink.

The value of short- and long-acting glucagon-like peptide-1 agonists in the management of type 2 diabetes mellitus: experience with exenatide.

Comparison of antiplatelet effect and safety of clopidogrel napadisilate with clopidogrel bisulfate in stroke patients: multicenter, randomized, open-label, phase 4, non-inferiority clinical trial.

Clustering medication adherence behavior based on beliefs in medicines and illness perceptions in patients taking asthma maintenance medications.

A comprehensive review of denosumab for bone metastasis in patients with solid tumors.

Warfarin time in therapeutic range and its impact on healthcare resource utilization and costs among patients with nonvalvular atrial fibrillation.

Incidence of postoperative residual neuromuscular blockade after general anesthesia: a prospective, multicenter, anesthetist-blind, observational study.

Burden of symptomatic uterine fibroids in Canadian women: a cohort study.

Indirect comparison of the antiviral efficacy of peginterferon alpha 2a plus ribavirin used with or without simeprevir in genotype 4 hepatitis C virus infection, where common comparator study arms are lacking: a special application of the matching adjusted indirect comparison methodology.

Impact of residential medication management reviews on anticholinergic burden in aged care residents.

Patiromer: a clinical review.

Why is residual neuromuscular blockade a universal issue?

Reaching more children with vaccines in developing countries: key challenges of innovation and delivery.

The profile of patients with chronic kidney disease who regularly present at an Australian general practice.

Non-transfusion-dependent thalassemia and thalassemia intermedia: epidemiology, complications, and management.

Real-world treatment patterns, comorbidities, and disease-related complications in patients with multiple myeloma in the United States.

Effects of rotigotine on daytime symptoms in patients with primary restless legs syndrome: a randomized, placebo-controlled study.

Year: 2016 Volume: 32 Issue: Supplementary 1

Year: 2016

Year: 2015 Volume: 31

Year: 2014 Volume: 30

Year: 2013 Volume: 29

Year: 2012 Volume: 28

Year: 2011 Volume: 27

Year: 2010 Volume: 26

Year: 2009 Volume: 25

Year: 2008 Volume: 24

Year: 2007 Volume: 23

Year: 2006 Volume: 22

Year: 1983 Volume: 8

Comparison of antiplatelet effect and safety of clopidogrel napadisilate with clopidogrel bisulfate in stroke patients: multicenter, randomized, open-label, phase 4, non-inferiority clinical trial.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Kang, Kyusik Lee, Se-Jin Kim, Hee-Jin Koh, Seong-Ho Kim, Byung Kun
Description	Author Affiliation: Kang K ( a a Department of Neurology , Eulji General Hospital, Eulji University , Seoul , Republic of Korea.); Lee SJ ( b b Department of Neurology , Yeungnam University Hospital , Daegu , Republic of Korea.); Kim HJ ( c c Department of Neurology , Hanyang University Seoul Hospital , Seoul , Republic of Korea.); Koh SH ( d d Department of Neurology , Hanyang University Guri Hospital , Guri-si , Republic of Korea.); Kim BK ( a a Department of Neurology , Eulji General Hospital, Eulji University , Seoul , Republic of Korea.)
Abstract	OBJECTIVE: Clopidogrel napadisilate has better chemical stability than clopidogrel bisulfate. Our trial's objective was to compare the efficacy and safety of clopidogrel napadisilate with clopidogrel bisulfate in participants with ischemic stroke. RESEARCH DESIGN AND METHODS: The study was a phase 4, 4 week, randomized, parallel-group, non-inferiority trial. Patients with ischemic stroke were randomized to receive either clopidogrel napadisilate 75 mg or clopidogrel bisulfate 75 mg. The primary study endpoint was change from baseline in P2Y12 percentage inhibition at week 4. The primary analysis was conducted in the per-protocol population. Non-inferiority was confirmed if the lower limit of the 95% confidence interval (CI) of the treatment difference was greater than or equal to -9.0% points. RESULTS: Sixty-one participants were randomly assigned clopidogrel napadisilate and 60 were randomly assigned clopidogrel bisulfate. Thirty-nine participants in the clopidogrel napadisilate group and 39 in the clopidogrel bisulfate group were analyzed for the primary endpoint. At 4 weeks, mean P2Y12 percentage inhibition had increased in both treatment groups. The estimated mean change from baseline was 22.3% with clopidogrel napadisilate and 21.4% with clopidogrel bisulfate; the estimated treatment difference of 0.9% (95% CI, -8.6 to 10.4) confirmed the non-inferiority of clopidogrel napadisilate to clopidogrel bisulfate. CONCLUSIONS: Clopidogrel napadisilate was non-inferior to clopidogrel bisulfate as assessed by change in P2Y12 percentage inhibition. Rates of adverse events were similar between the two groups. Therefore, clopidogrel napadisilate is a useful alternative option for the dosing of ischemic stroke patient populations.
File Format	HTM / HTML
ISSN	03007995
Issue Number	1
Volume Number	32
e-ISSN	14734877
Journal	Current Medical Research and Opinion
Language	English
Publisher	Taylor & Francis
Publisher Date	2016-01-01
Publisher Place	Great Britain (UK)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Medicine Platelet Aggregation Inhibitors Therapeutic Use Stroke Drug Therapy Ticlopidine Analogs & Derivatives Aged Female Humans Male Middle Aged Adverse Effects Clinical Trial, Phase Iv Comparative Study Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Medicine

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

Comparison of antiplatelet efficacy and tolerability of clopidogrel napadisilate with clopidogrel bisulfate in coronary artery disease patients after percutaneous coronary intervention: a prospective, multicenter, randomized, open-label, phase IV, noninferiority trial.

Comparison of effects of two different formulations of clopidogrel bisulfate tablets on platelet aggregation and bleeding time in healthy Korean volunteers: A single-dose, randomized, open-label, 1-week, two-period, phase IV crossover study.

Assessment of the efficacy and tolerability of clopidogrel napadisilate in Korean patients with coronary stenting: a multicenter, prospective, open-label, randomized trial.

Comparison of antiplatelet effect and tolerability of clopidogrel resinate with clopidogrel bisulfate in patients with coronary heart disease (CHD) or CHD-equivalent risks: a phase IV, prospective, double-dummy, parallel-group, 4-week noninferiority trial.

Platelet transfusion versus standard care after acute stroke due to spontaneous cerebral haemorrhage associated with antiplatelet therapy (PATCH): a randomised, open-label, phase 3 trial.

Comparative pharmacokinetics/pharmacodynamics of clopidogrel besylate and clopidogrel bisulfate in healthy Korean subjects.

Effect of clopidogrel besylate on platelet reactivity in patients with acute coronary syndromes. Comparison with clopidogrel hydrogen sulfate.

Effects of Clopidogrel Added to Aspirin in Patients with Recent Lacunar Stroke

Edaravone (radical scavenger) versus sodium ozagrel (antiplatelet agent) in acute noncardioembolic ischemic stroke (EDO trial).

Comparison of antiplatelet effect and safety of clopidogrel napadisilate with clopidogrel bisulfate in stroke patients: multicenter, randomized, open-label, phase 4, non-inferiority clinical trial.

Similar Documents

Comparison of antiplatelet efficacy and tolerability of clopidogrel napadisilate with clopidogrel bisulfate in coronary artery disease patients after percutaneous coronary intervention: a prospective, multicenter, randomized, open-label, phase IV, noninferiority trial.

Comparison of effects of two different formulations of clopidogrel bisulfate tablets on platelet aggregation and bleeding time in healthy Korean volunteers: A single-dose, randomized, open-label, 1-week, two-period, phase IV crossover study.

Assessment of the efficacy and tolerability of clopidogrel napadisilate in Korean patients with coronary stenting: a multicenter, prospective, open-label, randomized trial.

Comparison of antiplatelet effect and tolerability of clopidogrel resinate with clopidogrel bisulfate in patients with coronary heart disease (CHD) or CHD-equivalent risks: a phase IV, prospective, double-dummy, parallel-group, 4-week noninferiority trial.

Platelet transfusion versus standard care after acute stroke due to spontaneous cerebral haemorrhage associated with antiplatelet therapy (PATCH): a randomised, open-label, phase 3 trial.

Comparative pharmacokinetics/pharmacodynamics of clopidogrel besylate and clopidogrel bisulfate in healthy Korean subjects.

Effect of clopidogrel besylate on platelet reactivity in patients with acute coronary syndromes. Comparison with clopidogrel hydrogen sulfate.

Effects of Clopidogrel Added to Aspirin in Patients with Recent Lacunar Stroke

Edaravone (radical scavenger) versus sodium ozagrel (antiplatelet agent) in acute noncardioembolic ischemic stroke (EDO trial).

Comparison of antiplatelet effect and safety of clopidogrel napadisilate with clopidogrel bisulfate in stroke patients: multicenter, randomized, open-label, phase 4, non-inferiority clinical trial.