Abrupt Versus Tapered Interruption of Chronic Clopidogrel Therapy After DES Implantation

Prospective, Randomized, Double-Blind Trial of Abrupt and Tapered Interruption of Long-term Clopidogrel Therapy After Implantation of a Drug-Eluting Stent

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00640679

Acronym

ISAR-CAUTION

Enrollment

782

Registered

2008-03-21

Start date

2008-04-30

Completion date

2012-08-31

Last updated

2016-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Clopidogrel, Drug-eluting Stent

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).

Detailed description

A possible rebound in platelet activity after clopidogrel withdrawal has been suggested in patients on chronic clopidogrel therapy. However, a systematic evaluation of the role of rapid thienopyridine withdrawal on ischemic complications in patients with treated coronary artery disease has not been addressed by specifically designed studies. The objective of this study is to evaluate the safety and efficacy of abrupt or tapered interruption of chronic clopidogrel therapy after intracoronary drug-eluting stent implantation.

Interventions

DRUGAbrupt Clopidogrel Interruption

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.

DRUGClopidogrel Tapering

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
Composite of cardiac death, myocardial infarction, stent thrombosis, stroke, major bleeding or rehospitalization due to acute coronary syndrome.	3 months after randomization

Secondary

Measure	Time frame
The individual components of the primary endpoint. All cause mortality.	3 months after randomization

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026