NCT00640679

Brief Summary

The hypothesis to be tested is that gradual clopidogrel therapy cessation is associated with a superior clinical outcome compared with abrupt cessation (superiority hypothesis).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
782

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started Apr 2008

Longer than P75 for phase_4 coronary-artery-disease

Geographic Reach
1 country

2 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

March 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 21, 2008

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

July 27, 2016

Status Verified

June 1, 2012

Enrollment Period

4.3 years

First QC Date

March 17, 2008

Last Update Submit

July 26, 2016

Conditions

Coronary Artery Disease

Keywords

ClopidogrelDrug-eluting Stent

Outcome Measures

Primary Outcomes (1)

  • Composite of cardiac death, myocardial infarction, stent thrombosis, stroke, major bleeding or rehospitalization due to acute coronary syndrome.

    3 months after randomization

Secondary Outcomes (1)

  • The individual components of the primary endpoint. All cause mortality.

    3 months after randomization

Study Arms (2)

Clopidogrel Tapering

ACTIVE COMPARATOR
Drug: Clopidogrel Tapering

Abrupt Clopidogrel Interruption

ACTIVE COMPARATOR
Drug: Abrupt Clopidogrel Interruption

Interventions

Abrupt Clopidogrel InterruptionDRUG

Patients assigned to this group will receive Clopidogrel 75mg per day for an additional period of 4 weeks. Afterwards they will stop the drug abruptly.

Also known as: Plavix
Abrupt Clopidogrel Interruption
Clopidogrel TaperingDRUG

Patients assigned to this group will have Clopidogrel gradually decreased according to a fixed tapering schema of Clopidogrel and Placebo over 4 weeks.

Also known as: Plavix
Clopidogrel Tapering

Eligibility Criteria

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

You may qualify if:

  • Patients with planned interruption of chronic clopidogrel therapy after DES implantation
  • Informed, written consent by the patient

You may not qualify if:

  • Planned surgery within the next month
  • Active bleeding as reason for clopidogrel discontinuation
  • Concomitant coumadin therapy
  • Pregnancy (present, suspected or planned) or positive pregnancy test (In women with childbearing potential a negative pregnancy test is mandatory)
  • Malignancies or other comorbid conditions with a life expectancy of less than one year or that may result in protocol noncompliance.
  • Patient's inability to fully comply with the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

Medizinische Klinik, Klinikum rechts der Isar

Munich, 81675, Germany

Location

Related Publications (1)

  • Fiedler KA, Mehilli J, Kufner S, Schlichting A, Ibrahim T, Sibbing D, Ott I, Schunkert H, Laugwitz KL, Kastrati A, Schulz S. Randomised, double-blind trial on the value of tapered discontinuation of clopidogrel maintenance therapy after drug-eluting stent implantation. Intracoronary Stenting and Antithrombotic Regimen: CAUTION in Discontinuing Clopidogrel Therapy--ISAR-CAUTION. Thromb Haemost. 2014 Jun;111(6):1041-9. doi: 10.1160/TH13-11-0900. Epub 2014 Mar 13.

    PMID: 24633406RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Adnan Kastrati, MD

    Deutsches Herzzentrum Muenchen

    STUDY CHAIR

  • Julinda Mehilli, MD

    Deutsches Herzzentrum Muenchen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2008

First Posted

March 21, 2008

Study Start

April 1, 2008

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

July 27, 2016

Record last verified: 2012-06

Locations

DE(2)