NCT01508663

Brief Summary

The primary purpose of this study is to determine whether PCI added to OMT could be superior over OMT alone in the prevention of late adverse cardiac and cerebro-vascular events in elderly patients with coronary artery disease (CAD) during the additional 12 months.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 12, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Last Updated

January 12, 2012

Status Verified

January 1, 2012

Enrollment Period

3.5 years

First QC Date

January 3, 2012

Last Update Submit

January 9, 2012

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease 75years of age or older

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiac Event

    The primary end-point is the occurrence of major adverse cardiac event \[cardiovascular death, non-fatal MI (excluding periprocedural MI), stroke or any revascularization (PCI or coronary bypass surgery \[CABG\]) for 12 months following the randomization to the assigned management\]

    12month

Secondary Outcomes (1)

  • cardiac or non-cardiac major adverse event

    12month

Study Arms (2)

PCI+OMT group

EXPERIMENTAL

PCI (Everolimus Eluting Stent or Zotalolimus Eluting Stent) added to OMT after randomization and follow up for 12 months

Device: Everolimus Eluting Stent or Zotalolimus Eluting Stent

OMT alone group

ACTIVE COMPARATOR

OMT alone after randomization and follow up for 12 months

Drug: ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc.

Interventions

Everolimus Eluting Stent or Zotalolimus Eluting StentDEVICE

Everolimus Eluting Stent(Xience V, Xience prime) Zotalolimus Eluting Stent(Endeavor-resolute, Resolute Integrity)

PCI+OMT group
ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc.DRUG

one or two anti-platelet agents, beta-blockers, calcium channel blockers, nitrates, angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), and statin

OMT alone group

Eligibility Criteria

Age75 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients with CAD and those in whom initial CCS class I to III angina or Braunwald classification less than IIB
  • Patients with age 75 years or older
  • Patients receiving OMT (one or two anti-platelet agents, beta-blockers, calcium channel blockers, nitrates, angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), and statin)
  • Patients with stenosis of at least 70% in at least one proximal epicardial coronary artery or objective evidence of myocardial ischemia (substantial changes in ST-segment depression or T-wave inversion on the resting electrocardiogram or inducible ischemia with either exercise or pharmacologic vasodilator stress)
  • Patients with signed informed consent

You may not qualify if:

  • Patients with persistence of CCS IV angina
  • Resting chest pain (≥ Braunwald classification IIB)
  • Patients who experienced a markedly positive stress test (substantial ST- segment depression or hypotensive response during stage 1 of the Bruce protocol)
  • Patients with age 85 years or older
  • Patients with refractory CHF or cardiogenic shock
  • Patients with an EF of less than 30%
  • Patients who have received revascularization within the previous 6 months
  • Patients with coronary anatomy not suitable for PCI
  • Life expectancy ≤ 2 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Myeong-Ki, Hong

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Calcium Channel BlockersAngiotensin-Converting Enzyme InhibitorsHydroxymethylglutaryl-CoA Reductase InhibitorsNitrates

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Membrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesCalcium-Regulating Hormones and AgentsPhysiological Effects of DrugsCardiovascular AgentsTherapeutic UsesProtease InhibitorsEnzyme InhibitorsAnticholesteremic AgentsHypolipidemic AgentsAntimetabolitesLipid Regulating AgentsAnionsIonsElectrolytesInorganic ChemicalsNitric AcidNitrogen CompoundsOrganic Chemicals

Central Study Contacts

Myeong-Ki Hong, MD.PhD

CONTACT

+82 2 2228 8458mkhong61@yuhs.ac

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 3, 2012

First Posted

January 12, 2012

Study Start

August 1, 2010

Primary Completion

February 1, 2014

Last Updated

January 12, 2012

Record last verified: 2012-01

Locations

KR(1)