NSAIDs in Coronary Artery Disease Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT01402804
First received: July 25, 2011
Last updated: November 8, 2013
Last verified: November 2013
  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

Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • Thromboxane-levels and light-transmission aggregometry in response to arachidonic acid [ Time Frame: During hospital stay ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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
Study First Received: July 25, 2011
Last Updated: November 8, 2013
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on October 23, 2014