ST-segment Elevation Myocardial InfarctionPhase 4NCT02913469
Effects of Morphine on Loading-dose Ticagrelor in Patients With ST-segment Elevation Myocardial Infarction
A Phase 4 study testing Morphine, metoclopramide and saline in people with ST-segment Elevation Myocardial Infarction, run by General Hospital of Chinese Armed Police Forces at 1 site in China.
Trial summary
Percutaneous coronary intervention(PCI) has become the first choice for STEMI patients.According to the current guidelines,dual antiplatelet therapy with a P2Y12 receptor inhibitor and aspirin ,and intravenous injection of morphine therapy for chest pain relief in necessity play a pivotal role in the treatment of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction
- What is being tested?
- Morphine, metoclopramide and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2014to 15 Aug 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study-specific procedures
- Male or female aged from 18 to 80 years old
- Patients with STEMI scheduled to undergo PCI.
Who cannot join
- Hypersensitivity to the active substance or to any of the excipients
- Active bleeding or bleeding diathesis
- Previous transient ischemic attack
- Antiplatelet (clopidogrel, prasugrel, ticagrelor) administration in the week before the index event
- Known relevant hematological conditions
- Left ventricular ejection fraction ≤ 30%
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- Renal failure with creatinine ≥ 3 mg/dl
- History of liver disease
- Increased risk of bradycardia
- Concomitant therapy with drugs known to interfere with CYP3A4 metabolism.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cardiology Department, Chinese Armed Police Force Genral Hospital, Beijing China
Beijing, 100039
HUILIANG LIU, MD, +8610-57976531, liuhuiliang1961@163.com
JIAO ZHANG, MD, +8615011558161, 15011558161@163.com
About this study
Official title: The Effects of Morphine on Loading-dose Ticagrelor in Patients With ST-segment Elevation Myocardial Infarction Before Primary Percutaneous Coronary Interven Tion
Percutaneous coronary intervention(PCI) has become the first choice for STEMI patients.According to the current guidelines,dual antiplatelet therapy with a P2Y12 receptor inhibitor and aspirin ,and intravenous injection of morphine therapy for chest pain relief in necessity play a pivotal role in the treatment of patients with ST elevation myocardial infarction before primary percutaneous coronary intervention.And ticagrelor is recommended in patients with ST segment elevation myocardial infarction undergoing PCI, with class IB indication.Therefore coadministration of morphine and ticagrelor are commonplace.Currently, some studies have found that morphine delayed and attenuated exposure to ticagrelor,but it is not clear of the pathogenesis of it.Some researchers say that morphine results in a weaker and retarded antiplatelet effect of ticagrelor in STEMI patients before PCI by inhibition of gastrointestinal peristalsis and causing vomiting.The study is aimed at exploring whether morphine delay and attenuate exposure to ticagrelor and its antiplatelet effect.In addition, the trial will explore the possible mechanism which morphne delay and attenuate exposure to ticagrelor in patients with ST-segment elevation myocardial infarction before PCI.
Read the detailed description
The study is a single center, randomized, single-blind, controlled trial.From September 1st, 2014 to February 10, 2016，patients with STEMI who prepared to accept PCI were screened according to the inclusion criteria. All patients for eligibility for the study received orally a 300 mg loading dose (LD) of plain aspirin and a 180mg loading dose (LD) of plain ticagrelor and then signed a written informed consent to participate in the study.Then,the patients were randomly assigned to four treatment groups.The patients in group A would be administrated intravenous morphine 5mg and metoclopramide 10mg,the patients in group B would be administrated intravenous morphine 5mg and 0.9%normal saline 2ml,the patients in group C would be administrated intravenous metoclopramide 10mg and 0.9%normal saline 2ml, the patients in group D would be administrated intravenous 0.9%normal saline 2mland 0.9%normal saline 2ml. Subsequently，all patients would received orally plain aspirin 100mg once a day and plain ticagrelor 90mg twice a day and 1 month of follow-up.The investigators would calculate the platelet response index before LD and 0.5h,2h,8h after LD by platelet vasodilator-stimulated phosphoprotein phosphorylation assay with flow cytometry instrument(BD FACS Calibur). The primary study end-point was platelet response index by PRI VASP 2 hours after LD. Secondary end-points were (1) The platelet response index by PRI VASP half an hour and 8 hours after LD.(2)Record the electrocardiogram changes(the incidence of a 70% reduction after PCI ,TIMI flow of crime vessels(TIMI flow frames),the incidence of acute/subacute thrombotic events,the incidence of major adverse cardiovascular and cerebrovascular events,the incidence of primary and secondary bleeding.
- Being tested
- Morphine, metoclopramide, saline
- Keywords
- Morphine，Ticagrelor，STEMI，PCI
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Also called morphine hydrochloride
The patients in group A would be administrated intravenous morphine 5mg
metoclopramideDrug
Also called Pasprtin
the patients in group C would be administrated intravenous metoclopramide 10mg
salineDrug
Also called Physiological Saline
the patients in group D would be administrated intravenous 0.9%normal saline 2mland 0.9%normal saline 2ml.
| Study group | Role | What they receive |
|---|---|---|
| morphine+metoclopramide | Experimental | administrated intravenous morphine 5mg and metoclopramide 10mg Receives: Drug: Morphine; Drug: metoclopramide |
| morphine | Active comparator | avenous morphine 5mg and 0.9%normal saline 2ml Receives: Drug: Morphine; Drug: saline |
| metoclopramide | Sham comparator | intravenous metoclopramide 10mg and 0.9%normal saline 2ml Receives: Drug: metoclopramide; Drug: saline |
| placebo | Placebo comparator | intravenous 0.9%normal saline 2mland 0.9%normal saline 2ml Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Reactivity Index(PRI) Measured by VASP-P
Vasodilator-stimulated phosphoprotein(VASP) phosphorylation, a measure of P2Y12 receptor reactivity, was determined by flow cytometry with the use of the Platelet VASP-FCM Kit (Stago, France)and recorded as the platelet reactivity index
Measured: 2 hours after the loading dose of ticagrelor
Secondary outcomes (2)
Platelet Reactivity Index (PRI) Measured by VASP-P
Measured: 0.5hour,8hours after the loading dose of ticagrelor
the incidence of major adverse cardiovascular and cerebrovascular events
Measured: follow-up for 30 days after the loading dose of ticagrelor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study start12 Dec 2014
- Primary completion15 Aug 2020 (estimated)
- Study completion15 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-segment Elevation 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
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Chinese Armed Police Forces
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- huiliang liu, MD, Study chair, CHINESE ARMED POLICE FORCE GENRAL HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913469
- Sponsor's protocol ID
- Morphine & Ticagrelor
- Status last verified
- Mar 2020
- First submitted
- 9 Sep 2016
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Morphine on Loading-dose Ticagrelor in Patients With ST-segment Elevation Myocardial Infarction Before Primary Percutaneous Coronary Interven Tion
- ClinicalTrials.gov ID
- NCT02913469
- Acronym / sponsor ID
- Morphine & Ticagrelor
- Keywords
- Morphine，Ticagrelor，STEMI，PCI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- General Hospital of Chinese Armed Police ForcesUniversity, hospital or other
- Study start
- 12 Dec 2014 (actual)
- Primary completion
- 15 Aug 2020 (estimated)
- Study completion
- 15 Aug 2020 (estimated)
- First posted
- 23 Sep 2016 (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.
Percutaneous coronary intervention(PCI) has become the first choice for STEMI patients.According to the current guidelines,dual antiplatelet therapy with a P2Y12 receptor inhibitor and aspirin ,and intravenous injection of morphine therapy for chest pain relief in necessity play a pivotal role in the treatment of patients with ST elevation myocardial infarction before primary percutaneous coronary intervention.And ticagrelor is recommended in patients with ST segment elevation myocardial infarction undergoing PCI, with class IB indication.Therefore coadministration of morphine and ticagrelor are commonplace.Currently, some studies have found that morphine delayed and attenuated exposure to ticagrelor,but it is not clear of the pathogenesis of it.Some researchers say that morphine results in a weaker and retarded antiplatelet effect of ticagrelor in STEMI patients before PCI by inhibition of gastrointestinal peristalsis and causing vomiting.The study is aimed at exploring whether morphine delay and attenuate exposure to ticagrelor and its antiplatelet effect.In addition, the trial will explore the possible mechanism which morphne delay and attenuate exposure to ticagrelor in patients with ST-segment elevation myocardial infarction before PCI.
Detailed description
The study is a single center, randomized, single-blind, controlled trial.From September 1st, 2014 to February 10, 2016，patients with STEMI who prepared to accept PCI were screened according to the inclusion criteria. All patients for eligibility for the study received orally a 300 mg loading dose (LD) of plain aspirin and a 180mg loading dose (LD) of plain ticagrelor and then signed a written informed consent to participate in the study.Then,the patients were randomly assigned to four treatment groups.The patients in group A would be administrated intravenous morphine 5mg and metoclopramide 10mg,the patients in group B would be administrated intravenous morphine 5mg and 0.9%normal saline 2ml,the patients in group C would be administrated intravenous metoclopramide 10mg and 0.9%normal saline 2ml, the patients in group D would be administrated intravenous 0.9%normal saline 2mland 0.9%normal saline 2ml. Subsequently，all patients would received orally plain aspirin 100mg once a day and plain ticagrelor 90mg twice a day and 1 month of follow-up.The investigators would calculate the platelet response index before LD and 0.5h,2h,8h after LD by platelet vasodilator-stimulated phosphoprotein phosphorylation assay with flow cytometry instrument(BD FACS Calibur). The primary study end-point was platelet response index by PRI VASP 2 hours after LD. Secondary end-points were (1) The platelet response index by PRI VASP half an hour and 8 hours after LD.(2)Record the electrocardiogram changes(the incidence of a 70% reduction after PCI ,TIMI flow of crime vessels(TIMI flow frames),the incidence of acute/subacute thrombotic events,the incidence of major adverse cardiovascular and cerebrovascular events,the incidence of primary and secondary bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| morphine+metoclopramide | Experimental | Drug: Morphine, Drug: metoclopramideadministrated intravenous morphine 5mg and metoclopramide 10mg |
| morphine | Active comparator | Drug: Morphine, Drug: salineavenous morphine 5mg and 0.9%normal saline 2ml |
| metoclopramide | Sham comparator | Drug: metoclopramide, Drug: salineintravenous metoclopramide 10mg and 0.9%normal saline 2ml |
| placebo | Placebo comparator | Drug: salineintravenous 0.9%normal saline 2mland 0.9%normal saline 2ml |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provision of informed consent prior to any study-specific procedures
- Male or female aged from 18 to 80 years old
- Patients with STEMI scheduled to undergo PCI.
Key exclusion criteria (10 listed)
- Hypersensitivity to the active substance or to any of the excipients
- Active bleeding or bleeding diathesis
- Previous transient ischemic attack
- Antiplatelet (clopidogrel, prasugrel, ticagrelor) administration in the week before the index event
- Known relevant hematological conditions
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 |
|---|---|---|
| MorphineAlso: morphine hydrochlorideThe patients in group A would be administrated intravenous morphine 5mg | Drug | morphine, morphine+metoclopramide |
| metoclopramideAlso: Pasprtinthe patients in group C would be administrated intravenous metoclopramide 10mg | Drug | metoclopramide, morphine+metoclopramide |
| salineAlso: Physiological Salinethe patients in group D would be administrated intravenous 0.9%normal saline 2mland 0.9%normal saline 2ml. | Drug | metoclopramide, morphine, placebo |
Primary outcome
Platelet Reactivity Index(PRI) Measured by VASP-P
Time frame: 2 hours after the loading dose of ticagrelor
Vasodilator-stimulated phosphoprotein(VASP) phosphorylation, a measure of P2Y12 receptor reactivity, was determined by flow cytometry with the use of the Platelet VASP-FCM Kit (Stago, France)and recorded as the platelet reactivity index
2 secondary outcomes
Platelet Reactivity Index (PRI) Measured by VASP-P
Time frame: 0.5hour,8hours after the loading dose of ticagrelor
the incidence of major adverse cardiovascular and cerebrovascular events
Time frame: follow-up for 30 days after the loading dose of ticagrelor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Individual participant dataSharing planned: No
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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.
huiliang liu, MD study chair
CHINESE ARMED POLICE FORCE GENRAL HOSPITAL
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 Morphine, metoclopramide and saline in people with ST-segment Elevation Myocardial Infarction, run by General Hospital of Chinese Armed Police Forces at 1 site in China.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 31 Mar 2020. 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 China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact huiliang liu, MD (+8610 57976707, yueniaodream520@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet Reactivity Index(PRI) Measured by VASP-P (time frame: 2 hours after the loading dose of ticagrelor). 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 31 Mar 2020.