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Trial record 93 of 509 for:    ASPIRIN AND P2

Effects of Morphine on Loading-dose Ticagrelor in Patients With ST-segment Elevation Myocardial Infarction

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ClinicalTrials.gov Identifier: NCT02913469
Recruitment Status : Unknown
Verified September 2016 by General Hospital of Chinese Armed Police Forces.
Recruitment status was:  Recruiting
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
General Hospital of Chinese Armed Police Forces

Brief 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 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.

Condition or disease Intervention/treatment Phase
ST-segment Elevation Myocardial Infarction Drug: Morphine Drug: metoclopramide Drug: saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effects of Morphine on Loading-dose Ticagrelor in Patients With ST-segment Elevation Myocardial Infarction Before Primary Percutaneous Coronary Interven Tion
Study Start Date : December 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: morphine+metoclopramide
administrated intravenous morphine 5mg and metoclopramide 10mg
Drug: Morphine
The patients in group A would be administrated intravenous morphine 5mg
Other Name: morphine hydrochloride

Drug: metoclopramide
the patients in group C would be administrated intravenous metoclopramide 10mg
Other Name: Pasprtin

Active Comparator: morphine
avenous morphine 5mg and 0.9%normal saline 2ml
Drug: Morphine
The patients in group A would be administrated intravenous morphine 5mg
Other Name: morphine hydrochloride

Drug: saline
the patients in group D would be administrated intravenous 0.9%normal saline 2mland 0.9%normal saline 2ml.
Other Name: Physiological Saline

Sham Comparator: metoclopramide
intravenous metoclopramide 10mg and 0.9%normal saline 2ml
Drug: metoclopramide
the patients in group C would be administrated intravenous metoclopramide 10mg
Other Name: Pasprtin

Drug: saline
the patients in group D would be administrated intravenous 0.9%normal saline 2mland 0.9%normal saline 2ml.
Other Name: Physiological Saline

Placebo Comparator: placebo
intravenous 0.9%normal saline 2mland 0.9%normal saline 2ml
Drug: saline
the patients in group D would be administrated intravenous 0.9%normal saline 2mland 0.9%normal saline 2ml.
Other Name: Physiological Saline




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Platelet Reactivity Index (PRI) Measured by VASP-P [ Time Frame: 0.5hour,8hours after the loading dose of ticagrelor ]
  2. the incidence of major adverse cardiovascular and cerebrovascular events [ Time Frame: follow-up for 30 days after the loading dose of ticagrelor ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of informed consent prior to any study-specific procedures
  2. Male or female aged from 18 to 80 years old
  3. Patients with STEMI scheduled to undergo PCI.

Exclusion Criteria:

  1. Hypersensitivity to the active substance or to any of the excipients
  2. Active bleeding or bleeding diathesis
  3. Previous transient ischemic attack
  4. Antiplatelet (clopidogrel, prasugrel, ticagrelor) administration in the week before the index event
  5. Known relevant hematological conditions
  6. Left ventricular ejection fraction ≤ 30%
  7. Renal failure with creatinine ≥ 3 mg/dl
  8. History of liver disease
  9. Increased risk of bradycardia
  10. Concomitant therapy with drugs known to interfere with CYP3A4 metabolism.

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): NCT02913469


Contacts
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Contact: huiliang liu, MD +8610 57976707 yueniaodream520@126.com
Contact: peng ding, MD +8615300229301 562852538@qq.com

Locations
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China
Cardiology Department, Chinese Armed Police Force Genral Hospital, Beijing China Recruiting
Beijing, China, 100039
Contact: HUILIANG LIU, MD    +8610-57976531    liuhuiliang1961@163.com   
Contact: JIAO ZHANG, MD    +8615011558161    15011558161@163.com   
Sponsors and Collaborators
General Hospital of Chinese Armed Police Forces
Investigators
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Study Chair: huiliang liu, MD CHINESE ARMED POLICE FORCE GENRAL HOSPITAL

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Responsible Party: General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier: NCT02913469     History of Changes
Other Study ID Numbers: Morphine & Ticagrelor
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by General Hospital of Chinese Armed Police Forces:
Morphine,Ticagrelor,STEMI,PCI
Additional relevant MeSH terms:
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Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Morphine
Metoclopramide
Ticagrelor
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Gastrointestinal Agents