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

University Hospital of Bordeaux

Status and phase: Completed; Phase 4

Conditions: Impairment of Gastric Emptying; Acute Phase of Myocardial Infarction

Treatments: Drug: Paracetamol concentration time curve from 0 to 120 min

Study type: Interventional

Funder types: Other

Identifiers

NCT02251249

CHUBX 2013/19

Details and patient eligibility

About

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.

Full 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 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.

Paracetamol absorption test is a safe, cheap and well validated method to assess these times including during the STEMI period. This one consists in oral ingestion of 1.5g of paracetamol followed by the realization of the curve of concentration of paracetamol in plasma samples. These samples are taken at 15 min intervals during the first 2 hours.

In the same time the curve of Platelet reactivity Unit (PRU) obtained by VerifyNow® tests will be determined with the goal to establish a relation between gastric emptying times and delayed observed antiplatelet activity.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

STEMI Group

Experimental group

Treatment:

Drug: Paracetamol concentration time curve from 0 to 120 min

Stable patient Group

Other group

Description:

Patient referred for angioplasty for angina or non-ST-segment elevation myocardial infarction (NSTEMI)

Treatment:

Drug: Paracetamol concentration time curve from 0 to 120 min