Nobori Dual Antiplatelet Therapy as Appropriate Duration

This study is currently recruiting participants. (see Contacts and Locations)

Verified January 2014 by Associations for Establishment of Evidence in Interventions

Sponsor:

Information provided by (Responsible Party):

Associations for Establishment of Evidence in Interventions

ClinicalTrials.gov Identifier:

NCT01514227

First received: December 22, 2011

Last updated: January 8, 2014

Last verified: January 2014

History of Changes

Purpose

NIPPON trial is a prospective, randomized, trial comparing 6 and 18 months Dual Antiplatelet Therapy (DAPT) following Nobori stent deployment.

Condition	Intervention	Phase
Coronary Artery Disease	Drug: Aspirin or thienopyridine Drug: Aspirin and thienopyridine	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Nobori Dual Antiplatelet Therapy as Appropriate Duration.

Resource links provided by NLM:

Drug Information available for: Aspirin

U.S. FDA Resources

Further study details as provided by Associations for Establishment of Evidence in Interventions:

Primary Outcome Measures:

Net adverse clinical and cerebral event (NACCE) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
NACCE include all-cause death, non-fatal myocardial infarction, cerebrovascular events, and major bleeding.

Secondary Outcome Measures:

All-cause death [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Non-fatal myocardial infarction [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Cerebrovascular events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Major bleeding [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Rate of target lesion revascularization [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Minor bleeding [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	4598
Study Start Date:	December 2011
Estimated Study Completion Date:	November 2018
Estimated Primary Completion Date:	April 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Short-term DAPT (6 months) group 6 months DAPT (aspirin and thienopyridine) prescription following Nobori stent	Drug: Aspirin or thienopyridine Subjects randomized 6 month DAPT will be prescribed either aspirin or thienopyridine (clopidogrel or ticlopidine) following 6 months DAPT for the duration of study, which is left on the physician's discretion.
Experimental: Long-term DAPT (18 months) group 18 months DAPT (aspirin and thienopyridine) prescription following Nobori stent	Drug: Aspirin and thienopyridine Subjects randomized 18 month DAPT will be prescribed both aspirin and thienopyridine (clopidogrel or ticlopidine) for 18 month after stenting.

Eligibility


Ages Eligible for Study:	20 Years to 80 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects > 20 years old
Undergoing percutaneous intervention with Nobori deployment
No contraindication to prolonged DAPT

Exclusion Criteria:

Subjects absolutely necessitating continuous DAPT
Planned surgery necessitating discontinuation of antiplatelet therapy after enrollment.
Active pathological bleeding
Status of cardiogenic shock at enrollment
Pregnant women
Life expectancy of < 1.5 years
Subjects unable to give informed consent
Episode of stroke < 6 months
Subjects with allergies or hypersensitivity to material of coating, Biolimus A9, and antiplatelet drugs.
Subjects treated with other kind of DES or BMS during the index procedure
Previous intervention with DES < 6 months.
Study participation impractical per investigator judgment

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514227

Contacts


Contact: Masato Nakamura, M.D.	+81-3-3468-1251 ext 2317

Locations


Japan
Non-profit organization Associations for Establishment of Evidence in Interventions	Recruiting
Minato-ku, Tokyo, Japan, 105-0013
Contact: Masato Nakamura, M.D. +81-3-3468-1251 ext 2317

Sponsors and Collaborators

Associations for Establishment of Evidence in Interventions

More Information


Responsible Party:	Associations for Establishment of Evidence in Interventions
ClinicalTrials.gov Identifier:	NCT01514227 History of Changes
Other Study ID Numbers:	NIPPON 5.0
Study First Received:	December 22, 2011
Last Updated:	January 8, 2014
Health Authority:	Japan: Institutional Review Board

Additional relevant MeSH terms:


Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics	Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics

ClinicalTrials.gov processed this record on September 30, 2016

To Top