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

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ClinicalTrials.gov Identifier: NCT02251249
Recruitment Status : Unknown
Verified January 2017 by University Hospital, Bordeaux.
Recruitment status was:  Recruiting
First Posted : September 29, 2014
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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 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.


Condition or disease Intervention/treatment Phase
Impairment of Gastric Emptying Acute Phase of Myocardial Infarction Drug: Paracetamol concentration time curve from 0 to 120 min Phase 4

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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Actual Study Start Date : September 8, 2014
Estimated Primary Completion Date : June 8, 2017
Estimated Study Completion Date : June 8, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: STEMI Group Drug: Paracetamol concentration time curve from 0 to 120 min
It consists in oral ingestion of 1.5g of paracetamol (Contents of 3 Doliprane® capsules 500 mg) and 60 mg prasugrel (6 tablets Efient ® 10 mg) or 180 mg ticagrelor ( 2 tablets Brilique ® 90 mg) with water. Then Paracetamol concentration is 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.

Stable patient Group
Patient referred for angioplasty for angina or non-ST-segment elevation myocardial infarction (NSTEMI)
Drug: Paracetamol concentration time curve from 0 to 120 min
It consists in oral ingestion of 1.5g of paracetamol (Contents of 3 Doliprane® capsules 500 mg) and 60 mg prasugrel (6 tablets Efient ® 10 mg) or 180 mg ticagrelor ( 2 tablets Brilique ® 90 mg) with water. Then Paracetamol concentration is 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.




Primary Outcome Measures :
  1. Determination of the paracetamol concentration time curve at the time of STEMI Onset [ Time Frame: Every 15 minutes since inclusion (STEMI onset ) up to 120 minutes ]
    Taking of blood samples every 15 minutes for patients of STEMI Group

  2. Determination of the paracetamol concentration time curve 72 hours after time of STEMI Onset [ Time Frame: Every 15 minutes since 72 hours after STEMI onset up to 120 minutes ]
    Taking of blood samples every 15 minutes for patients of STEMI Group

  3. Determination of the paracetamol concentration time curve for Stable patient Group [ Time Frame: Every 15 minutes since inclusion up to 120 minutes ]
    Taking of blood samples every 15 minutes for Stable patient Group



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02251249


Contacts
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Contact: Lionel LEROUX, MD 05.57.65.67.87 lionel.leroux@chu-bordeaux.fr
Contact: Valérie Goin-Monsinjon valerie.goin@chu-bordeaux.fr

Locations
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France
CHU de Bordeaux - Hôpital du Haut Lévèque Recruiting
Pessac, France, 33604
Contact: Lionel LEROUX, MD       lionel.leroux@chu-bordeaux.fr   
Sub-Investigator: Frédéric CASASSUS, MD         
Principal Investigator: Lionel LEROUX, MD         
Sub-Investigator: Gérard BARBERO, MD         
Sub-Investigator: Patricia BERNADET, MD         
Sub-Investigator: Séverine BOUCARD, MD         
Sub-Investigator: Philippe BOUFFARD, MD         
Sub-Investigator: Olivier CASSONE, MD         
Sub-Investigator: Céline CHAUVEAU, MD         
Sub-Investigator: Benjamin CLOUZEAU, MD         
Sub-Investigator: Guillaume DELBAST, MD         
Sub-Investigator: Corinne DUBOIS-GONET, MD         
Sub-Investigator: Sébastien FRANC, MD         
Sub-Investigator: Hervé FRANCES, MD         
Sub-Investigator: Cédric GIL JARDINE, MD         
Sub-Investigator: Julie GOUGES, MD         
Sub-Investigator: Nathalie GOULOIS, MD         
Sub-Investigator: Virginie HEYDEL, MD         
Sub-Investigator: Philippe LABADIE, MD         
Sub-Investigator: Laure MAUGEIN, MD         
Sub-Investigator: François ORCIVAL, MD         
Sub-Investigator: Emilie RESPLANDY, MD         
Sub-Investigator: Philippe REVEL, MD         
Sub-Investigator: Béatrice SALAUN, MD         
Sub-Investigator: Aurélie SAN MIGUEL, MD         
Sub-Investigator: Oriana SANCHEZ, MD         
Sub-Investigator: Bruno SIMONNET, MD         
Sub-Investigator: Eric TENTILLIER, MD         
Sub-Investigator: Michel THICOIPE, MD         
Sub-Investigator: Grégoire VERSMEE, MD         
Sponsors and Collaborators
University Hospital, Bordeaux

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02251249     History of Changes
Other Study ID Numbers: CHUBX 2013/19
First Posted: September 29, 2014    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics