Status:
COMPLETED
LASER: Real Life Antithrombotic Stent Evaluation Registry
Lead Sponsor:
Stiftung Institut fuer Herzinfarktforschung
Conditions:
Percutaneous Coronary Intervention
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
915 Patients enrolled
Trial Details
Trial ID
NCT00865163
Start Date
November 1 2008
End Date
February 1 2014
Last Update
June 17 2016
Active Locations (2)
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1
Krankenhaus Düren
Düren, Germany, 52351
2
Institut für Herzinfarkforschung Ludwigshafen
Ludwigshafen, Germany, 67063