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
Sponsor:
Information provided by:
Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier:
NCT00865163
First received: March 18, 2009
Last updated: September 7, 2010
Last verified: September 2010
  Purpose

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.

Condition
PCI and All Anticoagulation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: LASER: Real Life Antithrombotic Stent Evaluation Registry

Further study details as provided by Stiftung Institut fuer Herzinfarktforschung:

Estimated Enrollment: 2000
Study Start Date: November 2008
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

Contacts
Contact: Uwe Zeymer, MD +49 621 503 ext 4045 zeymeru@klilu.de
Contact: Silke Hermann +49 621 503 ext 2805 hermann@herzinfarktforschung.de

Locations
Germany
Krankenhaus Düren Recruiting
Düren, Germany, 52351
Contact: Dietrich C. Gulba, MD    +49 2421-301310    dietrich_gulba@krankenhaus-dueren.de   
Principal Investigator: Dietrich C. Gulba, MD         
Institut für Herzinfarkforschung Ludwigshafen Recruiting
Ludwigshafen, Germany, 67063
Principal Investigator: Uwe Zeymer, MD         
Sponsors and Collaborators
Stiftung Institut fuer Herzinfarktforschung
Investigators
Principal Investigator: Dietrich C. Gulba, MD Krankenhaus Düren
  More Information

No publications provided

Responsible Party: Prof. Dr. Uwe Zeymer, Stiftung Institut fuer Herzinfarkforschung Ludwigshafen
ClinicalTrials.gov Identifier: NCT00865163     History of Changes
Other Study ID Numbers: LASER Registry
Study First Received: March 18, 2009
Last Updated: September 7, 2010
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on October 30, 2014