Coronary Artery DiseasePhase 4ISAR-SAFENCT00661206
Safety and Efficacy of Six Months Dual Antiplatelet Therapy After Drug-Eluting Stenting
A Phase 4 study testing Clopidogrel in people with Coronary Artery Disease, run by Deutsches Herzzentrum Muenchen at 40 sites in 13 countries.
Trial summary
The purpose of this study is to determine whether a 6 month duration of clopidogrel therapy after DES implantation is not inferior to that of a 12 month therapy. 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?
- Clopidogrel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,005 participants
- Where
- 40 sitesin 13 countries
- Study dates
- Sep 2008to Nov 2014
- 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 on clopidogrel therapy at 6 months (-1/+2 months) after DES implantation
- Informed, written consent by the patient
Who cannot join
- Age ≤18 years
- Clinically symptoms, proof of ischemia and/or presence of angiographic lesions requiring revascularization
- Previous stent thrombosis
- DES in left main coronary artery
- ST-elevation and non-ST-elevation myocardial infarction during the last 6 months
- Malignancies or other comorbid conditions with a life expectancy of less than one year or that may result in protocol noncompliance
Show all 13Show fewer
- Planned major surgery within the next 6 months with the need to discontinue antiplatelet therapy
- Active bleeding; bleeding diathesis; history intracranial bleeding
- Oral anticoagulation therapy with coumadin derivatives
- Known allergy or intolerance to the study medications: aspirin and clopidogrel
- Pregnancy (present, suspected or planned) or positive pregnancy test (In women with childbearing potential a negative pregnancy test is mandatory)
- Patient's inability to fully comply with the study protocol
- Prior enrollment in the same clinical trial.
Trial locations and contacts
40 sites in 13 countries.
40 sites in 13 countries
Germany23 sites
Herzzentrum Bad Krozingen
Bad Krozingen, 79189
Segeberger Kliniken GmbH
Bad Segeberg, 23795
Charité Berlin, Campus Benjamin Franklin
Berlin, 12203
Technische Universität Dresden
Dresden, 01309
Universitätsklinikum Erlangen
Erlangen, 91054
Klinikum Garmisch-Partenkirchen
Garmisch-Partenkirchen, 82467
Universitätsmedizin Göttingen
Göttingen, 37075
Klinikum Ingolstadt
Ingolstadt, 85049
MediClin Herzzentrum Lahr/Baden
Lahr, 77933
Krankenhaus Landshut-Achdorf
Landshut, 84036
Herzzentrum Leipzig
Leipzig, 04289
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, 23538
Klinikum München-Großhadern
München, 81377
Städtisches Klinikum München-Neuperlach
München, 81737
Deutsches Herzzentrum München
Munich, 81541
1st Medizinische Klinik, Klinikum rechts der Isar
Munich, 81675
Klinikum Bogenhausen
Munich, 81925
Lukaskrankenhaus GmbH, Städtische Kliniken Neuss
Neuss, 41464
Universitätsklinikum Regensburg
Regensburg, 93042
Klinikum Barmherzige Brüder Regensburg
Regensburg, 93049
Universitätsklinik Rostock
Rostock, 18057
Universitätsklinikum Ulm
Ulm, 89081
HELIOS Klinikum Wuppertal-Herzzentrum
Wuppertal, 42117
Netherlands4 sites
Catharina Hospital Eindhoven
Eindhoven, 5623
St. Antonius Hospital Department of Cardiology
Nieuwegein, 3435
Maasstad Ziekenhuis
Rotterdam, 3075
Isala klinieken, locatie Weezenlanden
Zwolle, 8011
Austria2 sites
Krankenanstalt Rudolfstiftung
Vienna, 1030
Wilhelminenspital Wien
Vienna, 1160
Japan2 sites
Tokai University School of Medicine
Isehara, 259 - 1193
Kyoto University Hospital
Kyoto, 606-8507
United States1 site
University of Florida, Health Science Center - Jacksonville
Jacksonville, Florida, 32209
About this study
Official title: Randomized, Double-Blind, Placebo-controlled Trial of 6 vs. 12 Months Clopidogrel Therapy After Implantation of a Drug-Eluting Stent
The purpose of this study is to determine whether a 6 month duration of clopidogrel therapy after DES implantation is not inferior to that of a 12 month therapy.
Read the detailed description
Drug elution from stent struts is associated with less smooth muscle cell proliferation and delayed stent strut re-endothelialization. Thus it seems conceivable that a longer duration of dual antiplatelet therapy (aspirin and clopidogrel) after DES implantation is needed. However, no studies have been done to investigate which is the optimal antiplatelet therapy duration after DES implantation. Therefore, the objective of the randomized, double-blind, placebo-controlled ISAR-SAFE study is to evaluate the safety and efficacy of a 6 month versus a 12 month duration of clopidogrel therapy after DES implantation.
Patients on clopidogrel therapy at least 6 months after DES implantation, who do not require a reintervention will be randomized to an additional 6 month period of clopidogrel or placebo. The patients will be followed-up for 9 months after randomization.
- Conditions
- Coronary Artery Disease
- Being tested
- Clopidogrel, Placebo
- 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.
ClopidogrelDrug
Also called Plavix, ACT-Code: B01AC/04
Patients on clopidogrel therapy at 6 months after implantation of a drug-eluting stent will be randomized to an additional 6 month period of clopidogrel 75mg per day
PlaceboDrug
Patients randomized in this group will receive placebo for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel | Active comparator | Not described Receives: Drug: Clopidogrel |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of death, myocardial infarction, stent thrombosis, stroke or TIMI major bleeding.
Measured: 9 months after randomization
Secondary outcomes (1)
The individual components of the primary endpoint
Measured: 9 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 posted18 Apr 2008 (estimated)
- Study startSep 2008
- Primary completionNov 2014 (estimated)
- Study completionNov 2014 (estimated)
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
- 4,005 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 MuenchenAdnan Kastrati, MD, Principal investigator, Deutsches Herzzentrum MuenchenJurriёn M ten Berg, MD, Principal investigator, St. Antonius Hospital Nieuwegein, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661206
- Sponsor's protocol ID
- GE IDE No. A01207
- Acronym
- ISAR-SAFE
- Status last verified
- Oct 2014
- First submitted
- 15 Apr 2008
- Last updated
- 9 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schulz-Schupke S, Byrne RA, Ten Berg JM, Neumann FJ, Han Y, Adriaenssens T, Tolg R, Seyfarth M, Maeng M, Zrenner B, Jacobshagen C, Mudra H, von Hodenberg E, Wohrle J, Angiolillo DJ, von Merzljak B, Rifatov N, Kufner S, Morath T, Feuchtenberger A, Ibrahim T, Janssen PW, Valina C, Li Y, Desmet W, Abdel-Wahab M, Tiroch K, Hengstenberg C, Bernlochner I, Fischer M, Schunkert H, Laugwitz KL, Schomig A, Mehilli J, Kastrati A; Intracoronary Stenting and Antithrombotic Regimen: Safety And EFficacy of 6 Months Dual Antiplatelet Therapy After Drug-Eluting Stenting (ISAR-SAFE) Trial Investigators. ISAR-SAFE: a randomized, double-blind, placebo-controlled trial of 6 vs. 12 months of clopidogrel therapy after drug-eluting stenting. Eur Heart J. 2015 May 21;36(20):1252-63. doi: 10.1093/eurheartj/ehu523. Epub 2015 Jan 23.
PubMed 25616646
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-controlled Trial of 6 vs. 12 Months Clopidogrel Therapy After Implantation of a Drug-Eluting Stent
- ClinicalTrials.gov ID
- NCT00661206
- Acronym / sponsor ID
- ISAR-SAFE / GE IDE No. A01207
- Conditions
- Coronary Artery Disease
- Keywords
- Clopidogrel, Drug-eluting stent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,005 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 18 Apr 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 purpose of this study is to determine whether a 6 month duration of clopidogrel therapy after DES implantation is not inferior to that of a 12 month therapy.
Detailed description
Drug elution from stent struts is associated with less smooth muscle cell proliferation and delayed stent strut re-endothelialization. Thus it seems conceivable that a longer duration of dual antiplatelet therapy (aspirin and clopidogrel) after DES implantation is needed. However, no studies have been done to investigate which is the optimal antiplatelet therapy duration after DES implantation. Therefore, the objective of the randomized, double-blind, placebo-controlled ISAR-SAFE study is to evaluate the safety and efficacy of a 6 month versus a 12 month duration of clopidogrel therapy after DES implantation.
Patients on clopidogrel therapy at least 6 months after DES implantation, who do not require a reintervention will be randomized to an additional 6 month period of clopidogrel or placebo. The patients will be followed-up for 9 months after randomization.
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 | Active comparator | Drug: Clopidogrel |
| Placebo | Placebo comparator | Drug: Placebo |
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 on clopidogrel therapy at 6 months (-1/+2 months) after DES implantation
- Informed, written consent by the patient
Key exclusion criteria (13 listed)
- Age ≤18 years
- Clinically symptoms, proof of ischemia and/or presence of angiographic lesions requiring revascularization
- Previous stent thrombosis
- DES in left main coronary artery
- ST-elevation and non-ST-elevation myocardial infarction during the last 6 months
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 |
|---|---|---|
| ClopidogrelAlso: Plavix, ACT-Code: B01AC/04Patients on clopidogrel therapy at 6 months after implantation of a drug-eluting stent will be randomized to an additional 6 month period of clopidogrel 75mg per day | Drug | Clopidogrel |
| PlaceboPatients randomized in this group will receive placebo for 6 months. | Drug | Placebo |
Primary outcome
Composite of death, myocardial infarction, stent thrombosis, stroke or TIMI major bleeding.
Time frame: 9 months after randomization
1 secondary outcome
The individual components of the primary endpoint
Time frame: 9 months after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2014.
- Derived from this study: PubMed 25616646Schulz-Schupke S, Byrne RA, Ten Berg JM, Neumann FJ, Han Y, Adriaenssens T, Tolg R, Seyfarth M, Maeng M, Zrenner B, Jacobshagen C, Mudra H, von Hodenberg E, Wohrle J, Angiolillo DJ, von Merzljak B, Rifatov N, Kufner S, Morath T, Feuchtenberger A, Ibrahim T, Janssen PW, Valina C, Li Y, Desmet W, Abdel-Wahab M, Tiroch K, Hengstenberg C, Bernlochner I, Fischer M, Schunkert H, Laugwitz KL, Schomig A, Mehilli J, Kastrati A; Intracoronary Stenting and Antithrombotic Regimen: Safety And EFficacy of 6 Months Dual Antiplatelet Therapy After Drug-Eluting Stenting (ISAR-SAFE) Trial Investigators. ISAR-SAFE: a randomized, double-blind, placebo-controlled trial of 6 vs. 12 months of clopidogrel therapy after drug-eluting stenting. Eur Heart J. 2015 May 21;36(20):1252-63. doi: 10.1093/eurheartj/ehu523. Epub 2015 Jan 23.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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
Adnan Kastrati, MD principal investigator
Deutsches Herzzentrum Muenchen
Jurriёn M ten Berg, MD principal investigator
St. Antonius Hospital Nieuwegein, Department of Cardiology
40 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clopidogrel in people with Coronary Artery Disease, run by Deutsches Herzzentrum Muenchen at 40 sites in 13 countries.
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 13 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: status not confirmed, as of the sponsor's last update on 9 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Germany, Netherlands, Austria, Japan, United States and 8 more countries. 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. Some participants in this study may receive a placebo. 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?
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 death, myocardial infarction, stent thrombosis, stroke or TIMI major bleeding. (time frame: 9 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 NCT00661206, 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 9 Oct 2014.