3-Month Discontinuation of Dual Antiplatelet Therapy After Ultimaster Sirolimus-Eluting Stent Implantation

NCT02837003 | Unknown DMC

• 1 other identifier: MODEL U-SES
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate safety of reduction of dual antiplatelet therapy period to three months after implantation of Ultimaster sirolimus-eluting stent (U-SES). Additionally to investigate appropriateness of thienopyridine monotherapy with discontinuation of aspirin.

Conditions

Coronary Artery Disease

Keywords

Drug-Eluting Stent

Outcome Measures

Primary Outcomes (1)

• Composite endpoint of all cause death in 12 months, myocardial infarction, stroke (ischemic and hemorrhagic), ARC definite/probable stent thrombosis and serious bleeding (BARC 3 or 5).

  12-month

Secondary Outcomes (22)

• Composite endpoint of all cause death in 3 months, myocardial infarction, stroke (ischemic and hemorrhagic), ARC definite/probable stent thrombosis and serious bleeding (BARC 3 or 5).

  3-month

• Major adverse cardiac event

  3-month

• Major adverse cardiac event

  12-month

• All cause death

  3-month

• All cause death

  12-month

Study Arms (2)

Experimental: Aspirin

Aspirin treatment for 3 months after the Ultimaster sirolimus-eluting stent implantation.

Drug: Aspirin

Experimental: Thienopyridine

Thienopyridine treatment for 3 months after the Ultimaster sirolimus-eluting Stent implantation.

Drug: Thienopyridine

Interventions

Aspirin DRUG

Discontinuation of aspirin at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.

Experimental: Aspirin

Thienopyridine DRUG

Discontinuation of thienopyridine at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.

Experimental: Thienopyridine

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The present study consisted of the following two study arms: the 3-month DAPT arm, a new registry arm in which 1,500 patients are consecutively recruite at 72 medical institutions; and the Longer DAPT arm, a historical control arm that consisted of 1,123 patients at 58 medical institutions.

You may qualify if:

• Patients with coronary artery lesion who received percutaneous coronary intervention using Ultimaster sirolimus-eluting stent.
• Patients considered appropriate to discontinue dual antiplatelet therapy at 3 months after stent implantation.
• Patients who have provided written informed consent.

You may not qualify if:

• Patients previously experienced stent thrombosis.
• Patients who are unable to clinical follow-up procedure specified in the protocal for the present study.
• Patients who are enrolled or planned to participate in another clinical trials of antiplatelet therapy.

Sponsors & Collaborators

• Teikyo University: lead

Study Sites (1)

Teikyo University Hospital

Tokyo, 173-8606, Japan

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Aspirin; thienopyridine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Ken Kozuma, MD, PhD

  Teikyo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ken Kozuma, MD, PhD

CONTACT

+81-3-3964-1211; PXE00364@nifty.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: July 19, 2016
• Study Start: July 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: August 2, 2016

Record last verified: 2016-07

Locations

JP (1)