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LASER: Real Life Antithrombotic Stent Evaluation Registry (LASER)

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ClinicalTrials.gov Identifier: NCT00865163
Recruitment Status : Completed
First Posted : March 19, 2009
Last Update Posted : June 17, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
LASER is designed to gather data about ischemic an bleeding complications for a period of 12 months after a PCI with the aim to optimize the therapy of these patients.

Condition or disease
Percutaneous Coronary Intervention

Detailed Description:

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.

Study Design

Study Type : Observational
Actual Enrollment : 915 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: LASER: Real Life Antithrombotic Stent Evaluation Registry
Study Start Date : November 2008
Primary Completion Date : February 2014
Study Completion Date : February 2014
Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00865163


Locations
Germany
Krankenhaus Düren
Düren, Germany, 52351
Institut für Herzinfarkforschung Ludwigshafen
Ludwigshafen, Germany, 67063
Sponsors and Collaborators
Stiftung Institut fuer Herzinfarktforschung
Investigators
Principal Investigator: Dietrich C. Gulba, MD Krankenhaus Düren
More Information

Responsible Party: Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier: NCT00865163     History of Changes
Other Study ID Numbers: LASER Registry
First Posted: March 19, 2009    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Stiftung Institut fuer Herzinfarktforschung:
Percutaneous Coronary Intervention
anticoagulation
PCI