Drug Drug Interactions of Aspirin and P2Y12-inhibitors

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Eva-Luise Hobl, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01369186
First received: June 7, 2011
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

Study Objective: To investigate potential drug-drug interactions (pharmacokinetics and pharmacodynamics) of morphine and antiplatelet drugs (aspirin, clopidogrel, prasugrel, ticagrelor)

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.


Condition Intervention Phase
VA Drug Interactions [VA Drug Interaction]
Myocardial Infarction
Drug: Morphine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 Medical University of Vienna:

Primary Outcome Measures:
  • Platelet function [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tmax [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Cmax [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: May 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Morphine Drug: Morphine
i.v. bolus injection
Other Name: Vendal
Placebo Comparator: Placebo Drug: Placebo
i.v. bolus injection
Other Name: Sodium chloride 0,9%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01369186

Contacts
Contact: Bernd Jilma, Prof. Dr. 43 1 40400 ext 2981 bernd.jilma@meduniwien.ac.at
Contact: Eva-Luise Hobl, Dr. 43 1 40400 ext 2981 eva-luise.hobl@meduniwien.ac.at

Locations
Austria
Medical University of Vienna, Department of Clinical Pharmacology Recruiting
Vienna, Austria, 1090
Contact: Bernd Jilma, Prof. Dr.    43 1 40400 ext 2981    bernd.jilma@meduniwien.ac.at   
Contact: Eva-Luise Hobl, Dr.    43 1 40400 ext 2981    eva-luise.hobl@meduniwien.ac.at   
Principal Investigator: Bernd Jilma, Prof. Dr.         
Sub-Investigator: Ulla Derhaschnig, Prof. Dr.         
Sub-Investigator: Christa Firbas, Dr.         
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided by Medical University of Vienna

Additional 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
Study First Received: June 7, 2011
Last Updated: May 21, 2013
Health Authority: Austria: Ethikkommission
Austria: Federal Office for Safety in Health Care

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
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014