Coronary Artery DiseasePhase 4ISAR-CAUTIONNCT00640679
Abrupt Versus Tapered Interruption of Chronic Clopidogrel Therapy After DES Implantation
A Phase 4 study testing Abrupt Clopidogrel Interruption and Clopidogrel Tapering in people with Coronary Artery Disease, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Abrupt Clopidogrel Interruption and Clopidogrel Tapering
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 782 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2008to Aug 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with planned interruption of chronic clopidogrel therapy after DES implantation
- Informed, written consent by the patient
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Deutsches Herzzentrum Muenchen
Munich, 80636
Medizinische Klinik, Klinikum rechts der Isar
Munich, 81675
About this study
Official title: Prospective, Randomized, Double-Blind Trial of Abrupt and Tapered Interruption of Long-term Clopidogrel Therapy After Implantation of a Drug-Eluting Stent
The hypothesis to be tested is that gradual clopidogrel therapy cessation is associated with a superior clinical outcome compared with abrupt cessation (superiority hypothesis).
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Abrupt Clopidogrel Interruption, Clopidogrel Tapering
- Keywords
- Clopidogrel, Drug-eluting Stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abrupt Clopidogrel InterruptionDrug
Also called Plavix
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.
Clopidogrel TaperingDrug
Also called Plavix
Patients assigned to this group will have Clopidogrel gradually decreased according to a fixed tapering schema of Clopidogrel and Placebo over 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel Tapering | Active comparator | Not described Receives: Drug: Clopidogrel Tapering |
| Abrupt Clopidogrel Interruption | Active comparator | Not described Receives: Drug: Abrupt Clopidogrel Interruption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of cardiac death, myocardial infarction, stent thrombosis, stroke, major bleeding or rehospitalization due to acute coronary syndrome.
Measured: 3 months after randomization
Secondary outcomes (1)
The individual components of the primary endpoint. All cause mortality.
Measured: 3 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Due to slow enrollment the study was stopped prematurely.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 782 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adnan Kastrati, MD, Study chair, Deutsches Herzzentrum MuenchenJulinda Mehilli, MD, Principal investigator, Deutsches Herzzentrum Muenchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640679
- Sponsor's protocol ID
- GE IDE No. A01308
- Acronym
- ISAR-CAUTION
- Status last verified
- Jun 2012
- First submitted
- 17 Mar 2008
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24633406
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double-Blind Trial of Abrupt and Tapered Interruption of Long-term Clopidogrel Therapy After Implantation of a Drug-Eluting Stent
- ClinicalTrials.gov ID
- NCT00640679
- Acronym / sponsor ID
- ISAR-CAUTION / GE IDE No. A01308
- Conditions
- Coronary Artery Disease
- Keywords
- Clopidogrel, Drug-eluting Stent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to slow enrollment the study was stopped prematurely.
- Enrolment
- 782 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 21 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel Tapering | Active comparator | Drug: Clopidogrel Tapering |
| Abrupt Clopidogrel Interruption | Active comparator | Drug: Abrupt Clopidogrel Interruption |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with planned interruption of chronic clopidogrel therapy after DES implantation
- Informed, written consent by the patient
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abrupt Clopidogrel InterruptionAlso: PlavixPatients assigned to this group will receive Clopidogrel 75mg per day for an additional period of 4 weeks. Afterwards they will stop the drug abruptly. | Drug | Abrupt Clopidogrel Interruption |
| Clopidogrel TaperingAlso: PlavixPatients assigned to this group will have Clopidogrel gradually decreased according to a fixed tapering schema of Clopidogrel and Placebo over 4 weeks. | Drug | Clopidogrel Tapering |
Primary outcome
Composite of cardiac death, myocardial infarction, stent thrombosis, stroke, major bleeding or rehospitalization due to acute coronary syndrome.
Time frame: 3 months after randomization
1 secondary outcome
The individual components of the primary endpoint. All cause mortality.
Time frame: 3 months after randomization
Results and safety
The study was stopped early (reason given: Due to slow enrollment the study was stopped prematurely.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
- Results publication: PubMed 24633406Fiedler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adnan Kastrati, MD study chair
Deutsches Herzzentrum Muenchen
Julinda Mehilli, MD principal investigator
Deutsches Herzzentrum Muenchen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Abrupt Clopidogrel Interruption and Clopidogrel Tapering in people with Coronary Artery Disease, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to slow enrollment the study was stopped prematurely.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of cardiac death, myocardial infarction, stent thrombosis, stroke, major bleeding or rehospitalization due to acute coronary syndrome. (time frame: 3 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00640679, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2016.