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NSAIDs in Coronary Artery Disease Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01402804
First Posted: July 26, 2011
Last Update Posted: November 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
  Purpose

Introduction:

Different groups already showed in retrospective subgroup analyses, that there is an increased risk for cardiovascular events in patients on a simultaneous ASA/NSAID treatment.

Methods:

Light-Transmission aggregometry

Hypothesis:

Simultaneous administration of different NSAIDs and ASA impair the platelet inhibiting effect of ASA.


Condition
CAD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-steroidal Anti-inflammatory Drugs Impair the Platelet Inhibiting Effect of Acetylsalicylic Acid in Coronary Artery Disease Patients

Resource links provided by NLM:


Further study details as provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • Thromboxane-levels and light-transmission aggregometry in response to arachidonic acid [ Time Frame: During hospital stay ]

Enrollment: 85
Study Start Date: July 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stable CAD, ASA, NSAID
Stable CAD, ASA

  Eligibility

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 a stable CAD undergoing coronary angiography in the Universitätsklinik Düsseldorf.
Criteria

Inclusion Criteria:

  • Patients on a simultaneous ASA, NSAID treatment
  • > 18 years

Exclusion Criteria:

  • unconsciousness, not able to consent
  • reanimation, cardiac shock
  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): NCT01402804


Locations
Germany
Heinrich-Heine-University
Düsseldorf, NRW, Germany, 40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
Principal Investigator: Amin Polzin, MD Klinik für Kariologie, Pneumologie und Angiologie, Universtiätsklinikum Düsseldorf
Study Chair: Tobias Zeus, MD Klinik für Kardiologie, Pneumologie und Angiologie
Study Chair: Thomas Hohlfeld, MD Institut für Pharmakologie und Klinische Pharmakologie, Heinrich-Heine-Univerität Düsseldorf
Study Director: Malte Kelm, MD Heinrich-Heine University, Duesseldorf
  More Information

Additional Information:
Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT01402804     History of Changes
Other Study ID Numbers: AGP-0001
First Submitted: July 25, 2011
First Posted: July 26, 2011
Last Update Posted: November 11, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents