LASER: Real Life Antithrombotic Stent Evaluation Registry

NCT ID: NCT00865163

Last Updated: 2016-06-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 915 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2014-02-28

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.

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.

Conditions

Percutaneous Coronary Intervention

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stiftung Institut fuer Herzinfarktforschung

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dietrich C. Gulba, MD

Role: PRINCIPAL_INVESTIGATOR

Krankenhaus Düren

Locations

Krankenhaus Düren

Düren, , Germany

Institut für Herzinfarkforschung Ludwigshafen

Ludwigshafen, , Germany

Countries

Germany

Other Identifiers

LASER Registry

Identifier Type: -

Identifier Source: org_study_id