LASER: Real Life Antithrombotic Stent Evaluation Registry
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Stiftung Institut fuer Herzinfarktforschung.
Recruitment status was Recruiting
Information provided by:
Stiftung Institut fuer Herzinfarktforschung
First received: March 18, 2009
Last updated: September 7, 2010
Last verified: September 2010
The LASER Registry will collect data from unselected patients on how the problem of stents on the background of full anticoagulation is approached by the investigators. On the collected data the LASER registry will
- document the frequently used treatment modalities how patients requiring stents on the background of full anticoagulation with Vitamin K Antagonists are currently managed
- will document the associated cardiac event rates with each currently used treatment strategy
- will document the associated bleeding rates with each currently used treatment strategy
With these data available, the LASER Registry will allow
- to define an optimised treatment regimen for the treatment of patients on full anticoagulation with Vitamin K Antagonists receiving one or more coronary stents
- to allow the appropriate sample size calculation for the design of a subsequent randomised comparison of continuous triple anticoagulation versus this optimised treatment regimen in such patients.
PCI and All Anticoagulation
||Observational Model: Cohort
Time Perspective: Prospective
||LASER: Real Life Antithrombotic Stent Evaluation Registry
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||November 2010 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients with significant symptomatic coronary artery disease who for this reason undergo PCI with implantation of one or more drug eluting stent(s) (DES) or bare metal stent(s) and requiring Vitamin K Antagonist based full anticoagulation therapy (target INR 2-4,5) for any clinical indication.
The LASER Registry will collect the data of 1000 patients with the need for oral anticoagulation and 1000 matched control patients without the need for oral anticoagulation.
- Patients with significant symptomatic coronary artery disease (stable angina class II or more (CCS) , unstable angina, NSTEMI, or STEMI) and who for this reason do undergo percutaneous coronary revascularization with one or more drug eluting stent(s) (DES) or bare metal stent(s)
- Patients requiring Vitamin K Antagonists based full anticoagulation therapy (target INR 2-4,5) for any clinical indication
- Age: >18 years; no upper age limit
- Informed consent has been obtained that the patient agrees to be fol-lowed up for up to one year
- Patients who have been treated with a combined anticoagulant & antiplatelet therapy within the previous two months
- Overt or constant occult bleeding that cannot adequately be treated (proton pump inhibitors, H2-blockers e.g.)
- Any contraindication to the use of thienopyridines
- Any contraindication to the use of aspirin
- Severe liver or kidney disease
- Any reason that creates sufficient doubts that follow-up can be obtained with reasonable efforts
- Any other reason that in the eye of the investigator makes the patient unsuitable for the participation in the registry
- For female patients only: pregnant or not on oral contraceptives or child bearing potential
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00865163
|Düren, Germany, 52351 |
|Contact: Dietrich C. Gulba, MD +49 2421-301310 firstname.lastname@example.org |
|Principal Investigator: Dietrich C. Gulba, MD |
|Institut für Herzinfarkforschung Ludwigshafen
|Ludwigshafen, Germany, 67063 |
|Principal Investigator: Uwe Zeymer, MD |
Stiftung Institut fuer Herzinfarktforschung
||Dietrich C. Gulba, MD
No publications provided
ClinicalTrials.gov processed this record on August 28, 2014
||Prof. Dr. Uwe Zeymer, Stiftung Institut fuer Herzinfarkforschung Ludwigshafen
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 18, 2009
||September 7, 2010
||Germany: Ethics Commission