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

Primary Purpose

Impairment of Gastric Emptying, Acute Phase of Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Paracetamol concentration time curve from 0 to 120 min
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Impairment of Gastric Emptying

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU de Bordeaux - Hôpital du Haut Lévèque

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

STEMI Group

Stable patient Group

Arm Description

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

Outcomes

Primary Outcome Measures

Determination of the paracetamol concentration time curve at the time of STEMI Onset
Taking of blood samples every 15 minutes for patients of STEMI Group
Determination of the paracetamol concentration time curve 72 hours after time of STEMI Onset
Taking of blood samples every 15 minutes for patients of STEMI Group
Determination of the paracetamol concentration time curve for Stable patient Group
Taking of blood samples every 15 minutes for Stable patient Group

Secondary Outcome Measures

Full Information

First Posted
September 24, 2014
Last Updated
February 8, 2022
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT02251249
Brief Title
Impairment of Gastric Emptying During Acute Phase of Myocardial Infarction. Impact on Oral Antiplatelet Treatment Efficacy. The GASTRIM Study.
Acronym
GASTRIM
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 8, 2014 (Actual)
Primary Completion Date
September 25, 2016 (Actual)
Study Completion Date
September 25, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impairment of Gastric Emptying, Acute Phase of Myocardial Infarction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STEMI Group
Arm Type
Experimental
Arm Title
Stable patient Group
Arm Type
Other
Arm Description
Patient referred for angioplasty for angina or non-ST-segment elevation myocardial infarction (NSTEMI)
Intervention Type
Drug
Intervention Name(s)
Paracetamol concentration time curve from 0 to 120 min
Intervention Description
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 Measure Information:
Title
Determination of the paracetamol concentration time curve at the time of STEMI Onset
Description
Taking of blood samples every 15 minutes for patients of STEMI Group
Time Frame
Every 15 minutes since inclusion (STEMI onset ) up to 120 minutes
Title
Determination of the paracetamol concentration time curve 72 hours after time of STEMI Onset
Description
Taking of blood samples every 15 minutes for patients of STEMI Group
Time Frame
Every 15 minutes since 72 hours after STEMI onset up to 120 minutes
Title
Determination of the paracetamol concentration time curve for Stable patient Group
Description
Taking of blood samples every 15 minutes for Stable patient Group
Time Frame
Every 15 minutes since inclusion up to 120 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CHU de Bordeaux - Hôpital du Haut Lévèque
City
Pessac
ZIP/Postal Code
33604
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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