LASER: Real Life Antithrombotic Stent Evaluation Registry

NCT00865163 | Completed

• 1 other identifier: LASER Registry
• Study Type: observational
• Target: 915
• Locations: 1 country
• Sites: 2

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.

Conditions

Percutaneous Coronary Intervention

Keywords

Percutaneous Coronary Intervention; anticoagulation; PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stiftung Institut fuer Herzinfarktforschung: lead

Study Sites (2)

Krankenhaus Düren

Düren, 52351, Germany

Location

Institut für Herzinfarkforschung Ludwigshafen

Ludwigshafen, 67063, Germany

Location

Study Officials

• Dietrich C. Gulba, MD

  Krankenhaus Düren

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2009
• First Posted: March 19, 2009
• Study Start: November 1, 2008
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: June 17, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)