NCT02402491

Brief Summary

Patients undergoing the percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) are enrolled. All patients will be randomized to receive either 12 months or 24 months of dual antiplatelet therapy with a P2Y12 receptor antagonist in addition to aspirin, all patients continue receiving aspirin indefinitely. The primary efficacy end points of this study are the incidence of a composite end point including all cause deaths, myocardial infarction, the incidence of Academic Research Consortium defined definite or probable stent thrombosis and stroke (MACCE) at 24 months. The primary safety end point is the incidence of GUSTO moderate or severe bleeding.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2013

Typical duration for phase_4

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

January 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

March 30, 2015

Status Verified

March 1, 2015

Enrollment Period

2.4 years

First QC Date

March 23, 2015

Last Update Submit

March 27, 2015

Conditions

Percutaneous Coronary Intervention

Keywords

Dual Antiplatelet TreatmentIn-Stent Restenosis

Outcome Measures

Primary Outcomes (1)

  • MACCE

    Incidence of a composite end point including all cause deaths, myocardial infarction, the incidence of Academic Research Consortium defined definite or probable stent thrombosis and stroke (MACCE) at 24 months.

    24 months

Secondary Outcomes (1)

  • Safety end point assessed by incidence of GUSTO moderate or severe bleeding.

    24 months

Study Arms (2)

24 months of P2Y12 receptor antagonist

ACTIVE COMPARATOR

Receive 24 months of dual antiplatelet therapy (with a P2Y12 receptor antagonist in addition to aspirin) after index procedure. All subjects receive aspirin for the duration of study.

Drug: 24 months of P2Y12 receptor antagonistDrug: Aspirin

12 months of P2Y12 receptor antagonist

PLACEBO COMPARATOR

Receive 12 months of dual antiplatelet therapy (with a P2Y12 receptor antagonist in addition to aspirin) after index procedure. All subjects receive aspirin for the duration of study.

Drug: 12 months of P2Y12 receptor antagonistDrug: Aspirin

Interventions

12 months of P2Y12 receptor antagonistDRUG

All subjects will be received 12 months of dual antiplatelet therapy with a P2Y12 receptor antagonist (clopidogrel/prasugrel/ticagrelor) in addition to aspirin.

12 months of P2Y12 receptor antagonist
24 months of P2Y12 receptor antagonistDRUG

All subjects will be received 24 months of dual antiplatelet therapy with a P2Y12 receptor antagonist (clopidogrel/prasugrel/ticagrelor) in addition to aspirin.

24 months of P2Y12 receptor antagonist
AspirinDRUG

The maintenance dose of aspirin is 100 mg daily, to be taken indefinitely.

12 months of P2Y12 receptor antagonist24 months of P2Y12 receptor antagonist

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects 18-80 years of age
  • Undergoing percutaneous intervention with stent deployment for the treatment of in-stent restenosis

You may not qualify if:

  • Pregnant women
  • Planned surgery necessitating discontinuation of antiplatelet therapy within the 24 months after enrollment
  • Current medical condition with a life expectancy of \<2 years
  • Concurrent enrollment in another device or drug study whose protocol specifically rules out concurrent enrollment
  • Subjects on warfarin or similar anticoagulant therapy
  • Subjects with hypersensitivity or allergies to one of the drugs
  • Subjects unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Interventions

Purinergic P2Y Receptor AntagonistsAspirin

Intervention Hierarchy (Ancestors)

Purinergic P2 Receptor AntagonistsPurinergic AntagonistsPurinergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of DrugsSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Yujie Zhou, MD, PhD

    Beijing Anzhen Hospital

    PRINCIPAL INVESTIGATOR

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 of cardiology, vice president of Beijing Anzhen Hospital

Study Record Dates

First Submitted

March 23, 2015

First Posted

March 30, 2015

Study Start

January 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

March 30, 2015

Record last verified: 2015-03

Locations

CN(1)