drugset / Trial / NCT02251249

Impairment of Gastric Emptying During Acute Phase of Myocardial Infarction. Impact on Oral Antiplatelet Treatment Efficacy. The GASTRIM Study.

NCT02251249

Phase 4 Completed 23 enrolled University Hospital, Bordeaux
RandomizedParallel-groupOpen-labelBasic science

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 during STEMI, limiting the use of morphine and encourage the use of prokinetic agents can be a first answer to optimize coronary angioplasty environment. Investigators propose a study to assess the gastric emptying times at the acute phase of myocardial infarction using a validated paracetamol absorption test. The STEMI group will be compared to in one hand, itself with measures performed 72 hours±12h after the event onset; and on the other hand, to a stable patient group referred for angioplasty for angina or non-ST-segment elevation myocardial infarction (NSTEMI). For STEMI group and stable patient group, the delay of apparition of Prasugrel or Ticagrelor efficacy will be determined by VerifyNow® test and correlated to gastric emptying times.

Timeline

Start
2014-12-08
Primary completion
2016-09-25
Completion
2016-09-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 1.5 g Oral
Subject Prasugrel Small molecule 60 mg Oral
Subject Ticagrelor Small molecule 180 mg Oral