ClinicalTrials.gov
ClinicalTrials.gov Menu

NSAIDs in Coronary Artery Disease Patients

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.
ClinicalTrials.gov Identifier: NCT01402804
Recruitment Status : Completed
First Posted : July 26, 2011
Last Update Posted : November 11, 2013
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

Brief Summary:

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 or disease
CAD

Study Type : Observational
Actual Enrollment : 85 participants
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
Study Start Date : July 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Stable CAD, ASA, NSAID
Stable CAD, ASA



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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Posted: July 26, 2011    Key Record Dates
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