Acute Myocardial InfarctionPhase 4MonAMINCT02627950
Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction
A Phase 4 study testing Morphinhydrochloricum, Metoclopramide and Ticagrelor in people with Acute Myocardial Infarction, run by University of Luebeck at 1 site in Germany.
Trial summary
The current prospective, randomized, controlled MonAMI trial aims to systematically examine the effects of morphine on the platelet inhibitory effects of the orally administered platelet inhibitor ticagrelor in patients with acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Morphinhydrochloricum, Metoclopramide and Ticagrelor
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2015to Oct 2018
- 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
- ST-elevation myocardial infarction < 24 h after symptom onset or non-ST-elevation myocardial infarction with persistent chest pain < 24 h after symptom onset
- Intended revascularization by primary percutaneous coronary intervention
- Informed consent
- Age ≥18 years
Who cannot join
- Age <18 years
- Active bleeding or bleeding diathesis
- Oral anticoagulation
- Current treatment with clopidogrel/prasugrel/ticagrelor/glycoprotein-IIb-IIIa-receptor-antagonists
- Current treatment with morphine and/or MCP <12 h
- Contraindication for treatment with platelet inhibitors
Show all 14Show fewer
- Fibrinolysis <48 h
- Percutaneous coronary intervention or coronary artery bypass grafting <3 months
- Known glomerular filtration rate <30 ml/min
- Severe liver dysfunction
- Hypersensitivity to ticagrelor or any excipients
- History of intracranial hemorrhage
- Known pregnancy, breast-feeding or intend to become pregnant during the study period
- Participation in other trial
Trial locations and contacts
1 site in 1 country.
About this study
The current prospective, randomized, controlled MonAMI trial aims to systematically examine the effects of morphine on the platelet inhibitory effects of the orally administered platelet inhibitor ticagrelor in patients with acute myocardial infarction. In addition, the potential positive or negative effects of MCP in combination with morphine on platelet inhibition will be studied.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Morphinhydrochloricum, Metoclopramide, Ticagrelor, Isotonic sodium chloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphinhydrochloricumDrug
Also called Morphin-hameln (manufacturer: hameln pharmaceuticals)
5 mg morphine intravenously
MetoclopramideDrug
Also called MCP-ratiopharm (manufacturer: Ratiopharm)
10 mg MCP intravenously
TicagrelorDrug
Also called Brilique (manufacturer: AstraZeneca)
180 mg ticagrelor orally
Isotonic sodium chlorideDrug
Also called NaCl (manufacturer: Berlin-Chemie Menarini)
10 ml NaCl 0.9% intravenously
| Study group | Role | What they receive |
|---|---|---|
| Isotonic sodium chloride + Ticagrelor | Active comparator | 46 patients with NaCl i.v. and 180 mg ticagrelor orally pre revascularization plus medical standard therapy Receives: Drug: Ticagrelor; Drug: Isotonic sodium chloride |
| Morphinhydrochloricum + Ticagrelor | Experimental | 46 patients with 5 mg morphine i.v. and 180 mg ticagrelor pre revascularization plus medical standard therapy Receives: Drug: Morphinhydrochloricum; Drug: Ticagrelor |
| Morphinhydrochloricum + Ticagrelor + Metoclopramide | Experimental | 46 patients with 5 mg morphine i.v. and 10 mg MCP i.v. and 180 mg ticagrelor pre revascularization plus medical standard therapy Receives: Drug: Morphinhydrochloricum; Drug: Metoclopramide; Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet activity 2 hours after administration of loading dose of ticagrelor measured by VerifyNow-P2Y12-test
Measured: 2 hours
Secondary outcomes (6)
Platelet reactivity 0.5, 1, 4, 6 and 24 hours after loading dose of ticagrelor measured by VerifyNow-P2Y12-test
Measured: 0.5, 1, 4, 6 h and 24 hours
Platelet reactivity 0.5, 1, 2, 4, 6 and 24 hours after loading dose of ticagrelor measured by Vasodilator Stimulated Phosphoprotein-test
Measured: 0.5, 1, 2, 4, 6 h and 24 hours
Percentage of patients with high on-treatment platelet reactivity 0.5, 1, 2, 4, 6 and 24 hours after loading dose of ticagrelor (measured by VerifyNow-P2Y12-test)
Measured: 0.5, 1, 2, 4, 6 h and 24 hours
Ticagrelor plasma levels and levels of active serum metabolites after 0.5, 1, 2, 4, 6 and 24 hours
Measured: 0.5, 1, 2, 4, 6 h and 24 hours
Infarct size measured by delayed enhancement magnetic resonance imaging
Measured: Day 1-4
Microvascular obstruction measured by delayed enhancement magnetic resonance imaging
Cardiac magnetic resonance imaging equivalent of angiographic no-reflow, expressed as percentage of left ventricular mass
Measured: Day 1-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Ingo Eitel, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627950
- Sponsor's protocol ID
- ESR-14-10498
- Acronym
- MonAMI
- Status last verified
- Aug 2019
- First submitted
- 3 Dec 2015
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Stiermaier T, Schaefer P, Meyer-Saraei R, Saad M, de Waha-Thiele S, Poss J, Fuernau G, Graf T, Kurz T, Frydrychowicz A, Barkhausen J, Desch S, Thiele H, Eitel I. Impact of Morphine Treatment With and Without Metoclopramide Coadministration on Myocardial and Microvascular Injury in Acute Myocardial Infarction: Insights From the Randomized MonAMI Trial. J Am Heart Assoc. 2021 May 4;10(9):e018881. doi: 10.1161/JAHA.120.018881. Epub 2021 Apr 26.
PubMed 33899498Saad M, Meyer-Saraei R, de Waha-Thiele S, Stiermaier T, Graf T, Fuernau G, Langer HF, Kurz T, Poss J, Barkhausen J, Desch S, Eitel I, Thiele H. Impact of Morphine Treatment With and Without Metoclopramide Coadministration on Ticagrelor-Induced Platelet Inhibition in Acute Myocardial Infarction: The Randomized MonAMI Trial. Circulation. 2020 Apr 21;141(16):1354-1356. doi: 10.1161/CIRCULATIONAHA.119.042816. Epub 2020 Apr 20. No abstract available.
PubMed 32310699
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02627950
- Acronym / sponsor ID
- MonAMI / ESR-14-10498
- Conditions
- Acute Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 11 Dec 2015 (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.
The current prospective, randomized, controlled MonAMI trial aims to systematically examine the effects of morphine on the platelet inhibitory effects of the orally administered platelet inhibitor ticagrelor in patients with acute myocardial infarction. In addition, the potential positive or negative effects of MCP in combination with morphine on platelet inhibition will be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Isotonic sodium chloride + Ticagrelor | Active comparator | Drug: Ticagrelor, Drug: Isotonic sodium chloride46 patients with NaCl i.v. and 180 mg ticagrelor orally pre revascularization plus medical standard therapy |
| Morphinhydrochloricum + Ticagrelor | Experimental | Drug: Morphinhydrochloricum, Drug: Ticagrelor46 patients with 5 mg morphine i.v. and 180 mg ticagrelor pre revascularization plus medical standard therapy |
| Morphinhydrochloricum + Ticagrelor + Metoclopramide | Experimental | Drug: Morphinhydrochloricum, Drug: Metoclopramide, Drug: Ticagrelor46 patients with 5 mg morphine i.v. and 10 mg MCP i.v. and 180 mg ticagrelor pre revascularization plus medical standard therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ST-elevation myocardial infarction < 24 h after symptom onset or non-ST-elevation myocardial infarction with persistent chest pain < 24 h after symptom onset
- Intended revascularization by primary percutaneous coronary intervention
- Informed consent
- Age ≥18 years
Key exclusion criteria (14 listed)
- Age <18 years
- Active bleeding or bleeding diathesis
- Oral anticoagulation
- Current treatment with clopidogrel/prasugrel/ticagrelor/glycoprotein-IIb-IIIa-receptor-antagonists
- Current treatment with morphine and/or MCP <12 h
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 |
|---|---|---|
| MorphinhydrochloricumAlso: Morphin-hameln (manufacturer: hameln pharmaceuticals)5 mg morphine intravenously | Drug | Morphinhydrochloricum + Ticagrelor, Morphinhydrochloricum + Ticagrelor + Metoclopramide |
| MetoclopramideAlso: MCP-ratiopharm (manufacturer: Ratiopharm)10 mg MCP intravenously | Drug | Morphinhydrochloricum + Ticagrelor + Metoclopramide |
| TicagrelorAlso: Brilique (manufacturer: AstraZeneca)180 mg ticagrelor orally | Drug | Isotonic sodium chloride + Ticagrelor, Morphinhydrochloricum + Ticagrelor, Morphinhydrochloricum + Ticagrelor + Metoclopramide |
| Isotonic sodium chlorideAlso: NaCl (manufacturer: Berlin-Chemie Menarini)10 ml NaCl 0.9% intravenously | Drug | Isotonic sodium chloride + Ticagrelor |
Primary outcome
Platelet activity 2 hours after administration of loading dose of ticagrelor measured by VerifyNow-P2Y12-test
Time frame: 2 hours
6 secondary outcomes
Platelet reactivity 0.5, 1, 4, 6 and 24 hours after loading dose of ticagrelor measured by VerifyNow-P2Y12-test
Time frame: 0.5, 1, 4, 6 h and 24 hours
Platelet reactivity 0.5, 1, 2, 4, 6 and 24 hours after loading dose of ticagrelor measured by Vasodilator Stimulated Phosphoprotein-test
Time frame: 0.5, 1, 2, 4, 6 h and 24 hours
Percentage of patients with high on-treatment platelet reactivity 0.5, 1, 2, 4, 6 and 24 hours after loading dose of ticagrelor (measured by VerifyNow-P2Y12-test)
Time frame: 0.5, 1, 2, 4, 6 h and 24 hours
Ticagrelor plasma levels and levels of active serum metabolites after 0.5, 1, 2, 4, 6 and 24 hours
Time frame: 0.5, 1, 2, 4, 6 h and 24 hours
Infarct size measured by delayed enhancement magnetic resonance imaging
Time frame: Day 1-4
Microvascular obstruction measured by delayed enhancement magnetic resonance imaging
Time frame: Day 1-4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Derived from this study: PubMed 33899498Stiermaier T, Schaefer P, Meyer-Saraei R, Saad M, de Waha-Thiele S, Poss J, Fuernau G, Graf T, Kurz T, Frydrychowicz A, Barkhausen J, Desch S, Thiele H, Eitel I. Impact of Morphine Treatment With and Without Metoclopramide Coadministration on Myocardial and Microvascular Injury in Acute Myocardial Infarction: Insights From the Randomized MonAMI Trial. J Am Heart Assoc. 2021 May 4;10(9):e018881. doi: 10.1161/JAHA.120.018881. Epub 2021 Apr 26.
- Derived from this study: PubMed 32310699Saad M, Meyer-Saraei R, de Waha-Thiele S, Stiermaier T, Graf T, Fuernau G, Langer HF, Kurz T, Poss J, Barkhausen J, Desch S, Eitel I, Thiele H. Impact of Morphine Treatment With and Without Metoclopramide Coadministration on Ticagrelor-Induced Platelet Inhibition in Acute Myocardial Infarction: The Randomized MonAMI Trial. Circulation. 2020 Apr 21;141(16):1354-1356. doi: 10.1161/CIRCULATIONAHA.119.042816. Epub 2020 Apr 20. No abstract available.
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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 Morphinhydrochloricum, Metoclopramide and Ticagrelor in people with Acute Myocardial Infarction, run by University of Luebeck at 1 site in Germany.
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 4 inclusion and 14 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: finished, as of the sponsor's last update on 8 Aug 2019. 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Platelet activity 2 hours after administration of loading dose of ticagrelor measured by VerifyNow-P2Y12-test (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02627950, which also lists 2 linked publications.
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 8 Aug 2019.