Status:
COMPLETED
Impairment of Gastric Emptying During Acute Phase of Myocardial Infarction. Impact on Oral Antiplatelet Treatment Efficacy. The GASTRIM Study.
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Impairment of Gastric Emptying
Acute Phase of Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Oral antiplatelet therapy is a key treatment of the STEMI (ST elevation myocardial infarction). Delayed action isn't suitable and has to be elucidated. If a delayed gastric emptying time is observed d...
Detailed Description
Oral antiplatelet therapy is a key treatment of the STEMI (ST elevation myocardial infarction). Delayed action isn't suitable and has to be elucidated. If a delayed gastric emptying time is observed d...
Eligibility Criteria
Inclusion
- Patient over 18 years weighing between 65 and 85 Kg
- Referred for STEMI within 6 hours from beginning of chest pain or stable coronary artery disease requiring a loading dose of Prasugrel or Ticagrelor according to the international recommendations.
- No previous treatment with Clopidogrel, Prasugrel or Ticagrelor.
- Patient fasting for at least 6 hours.
- Affiliate or receiving a social security system.
- Written informed consent.
Exclusion
- Allergy or contraindication to paracetamol, Prasugrel or Ticagrelor
- Paracetamol ingestion in the previous 48 hours
- Patient treated with drugs supposed to alter gastric emptying times (calcium antagonists, Alimentary tract treatments, opioid analgesics, tricyclic antidepressants, antibiotics).
- Conditions or pathologies supposed to alter gastric emptying times (Thyroid dysfunction, chronic renal failure, Parkinson's disease, scleroderma, amyloidosis, any gastrointestinal disease, any not cured malignancy, and any advanced psychiatric or neurological disease).
- Presence of vomiting
- Cardiogenic shock, ventricular arrhythmia or resuscitated cardiac arrest
- Hepatic insufficiency
- Severe respiratory disease
- Pregnant or breastfeeding women
Key Trial Info
Start Date :
December 8 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2016
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT02251249
Start Date
December 8 2014
End Date
September 25 2016
Last Update
February 14 2022
Active Locations (1)
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1
CHU de Bordeaux - Hôpital du Haut Lévèque
Pessac, France, 33604