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Drug Drug Interactions of Aspirin and P2Y12-inhibitors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01369186
First Posted: June 8, 2011
Last Update Posted: March 27, 2017
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):
Eva-Luise Hobl, Medical University of Vienna
  Purpose
Study Objective: To investigate potential drug-drug interactions (pharmacokinetics and pharmacodynamics) of morphine and antiplatelet drugs (aspirin, clopidogrel, prasugrel, ticagrelor)

Condition Intervention Phase
Drug Interaction Potentiation Myocardial Infarction Drug: Morphine Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Drug Drug Interactions of Antiplatelet Drugs and Morphine

Resource links provided by NLM:


Further study details as provided by Eva-Luise Hobl, Medical University of Vienna:

Primary Outcome Measures:
  • Platelet function [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • Tmax [ Time Frame: 14 days ]
  • Cmax [ Time Frame: 14 days ]

Enrollment: 95
Study Start Date: May 2011
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Morphine
Vendal 5 mg i.v. bolus injection
Drug: Morphine
i.v. bolus injection
Other Name: Vendal
Placebo Comparator: Placebo
Sodium chloride 0.9% i.v. bolus injection
Drug: Placebo
i.v. bolus injection
Other Name: Sodium chloride 0,9%

Detailed Description:
Rationale: Opiates reduce the intestinal resorption of orally administered drugs such as paracetamol. Because morphine is often injected to relieve pain in patients with myocardial infarction, it is of particular interest if morphine may decrease the rate of absorption of antiplatelet drugs. Results of this study will provide essential information for the use of morphine and antiplatelet drugs in clinical practice, in particular in myocardial infarction.
  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:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers ≥ 18 years of age
  • No intake of NSARs and P2Y12-inhibitors within 14 days before study entry
  • Written informed consent

Exclusion Criteria:

  • Known coagulation disorders
  • Relevant impairment of hepatic function (elevated transaminases, ≥ 2 fold)
  • Relevant impairment of renal function
  • Infectious diseases (HIV, hepatitis B and C)
  • Gestation and lactation
  • Clinically relevant abnormal laboratory values
  • Use of medication during 2 weeks before the start of the study, which may affect the validity of the study
  • General contraindications for aspirin (resp. clopidogrel, prasugrel, ticagrelor) and morphine
  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): NCT01369186


Locations
Austria
Medical University of Vienna, Department of Clinical Pharmacology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Bernd Jilma, Prof. Dr. Medical University of Vienna
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eva-Luise Hobl, Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01369186     History of Changes
Other Study ID Numbers: 2010-023761-22
First Submitted: June 7, 2011
First Posted: June 8, 2011
Last Update Posted: March 27, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents


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