Impairment of Gastric EmptyingPhase 4GASTRIMNCT02251249
Impairment of Gastric Emptying During Acute Phase of Myocardial Infarction. Impact on Oral Antiplatelet Treatment Efficacy. The GASTRIM Study.
A Phase 4 study testing Paracetamol concentration time curve from 0 to 120 min in people with Impairment of Gastric Emptying and Acute Phase of Myocardial Infarction, run by University Hospital, Bordeaux at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Impairment of Gastric Emptying, Acute Phase of Myocardial Infarction
- What is being tested?
- Paracetamol concentration time curve from 0 to 120 min
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2014to 25 Sep 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- Hepatic insufficiency
- Severe respiratory disease
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Paracetamol concentration time curve from 0 to 120 min
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol concentration time curve from 0 to 120 minDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| STEMI Group | Experimental | Not described Receives: Drug: Paracetamol concentration time curve from 0 to 120 min |
| Stable patient Group | Other | Patient referred for angioplasty for angina or non-ST-segment elevation myocardial infarction (NSTEMI) Receives: Drug: Paracetamol concentration time curve from 0 to 120 min |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Every 15 minutes since inclusion (STEMI onset ) up to 120 minutes
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
Measured: Every 15 minutes since 72 hours after STEMI onset up to 120 minutes
Determination of the paracetamol concentration time curve for Stable patient Group
Taking of blood samples every 15 minutes for Stable patient Group
Measured: Every 15 minutes since inclusion up to 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study start8 Dec 2014
- Primary completion25 Sep 2016
- Study completion25 Sep 2016
Why it stopped: target number of inclusion not reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impairment of Gastric EmptyingStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251249
- Sponsor's protocol ID
- CHUBX 2013/19
- Other IDs
- 2013-004347-23
- Acronym
- GASTRIM
- Status last verified
- Feb 2022
- First submitted
- 24 Sep 2014
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impairment of Gastric Emptying During Acute Phase of Myocardial Infarction. Impact on Oral Antiplatelet Treatment Efficacy. The GASTRIM Study.
- ClinicalTrials.gov ID
- NCT02251249
- Acronym / sponsor ID
- GASTRIM / CHUBX 2013/19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: target number of inclusion not reached
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 8 Dec 2014 (actual)
- Primary completion
- 25 Sep 2016 (actual)
- Study completion
- 25 Sep 2016 (actual)
- First posted
- 29 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEMI Group | Experimental | Drug: Paracetamol concentration time curve from 0 to 120 min |
| Stable patient Group | Other | Drug: Paracetamol concentration time curve from 0 to 120 minPatient referred for angioplasty for angina or non-ST-segment elevation myocardial infarction (NSTEMI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paracetamol concentration time curve from 0 to 120 minIt 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. | Drug | STEMI Group, Stable patient Group |
Primary outcome
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
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
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
Results and safety
The study was stopped early (reason given: target number of inclusion not reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paracetamol concentration time curve from 0 to 120 min in people with Impairment of Gastric Emptying and Acute Phase of Myocardial Infarction, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: target number of inclusion not reached). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.