search
Back to results

Influence of Morphine on Pharmacokinetics and Pharmacodynamics of Ticagrelor in Patients With Acute Myocardial Infarction (IMPRESSION)

Primary Purpose

ST-segment Elevation Myocardial Infarction, Non-ST-segment Elevation Myocardial Infarction, VA Drug Interactions

Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Morphine
Placebo
Ticagrelor
Sponsored by
Collegium Medicum w Bydgoszczy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST-segment Elevation Myocardial Infarction focused on measuring ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, ticagrelor, morphine, pharmacokinetics, pharmacodynamics, drug interactions, VASP assay, Multiple Electrode Aggregometry, VerifyNow

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • provision of informed consent prior to any study specific procedures
  • diagnosis of acute ST-segment elevation myocardial infarction or acute non-ST-segment elevation myocardial infarction
  • male or non-pregnant female, aged 18-80 years old
  • provision of informed consent for angiography and PCI

Exclusion Criteria:

  • chest pain described by the patient as unbearable or patient's request for analgesics
  • prior morphine administration during the current STEMI or NSTEMI
  • treatment with ticlopidine, clopidogrel, prasugrel or ticagrelor within 14 days before the study enrollment
  • hypersensitivity to ticagrelor
  • current treatment with oral anticoagulant or chronic therapy with low-molecular-weight heparin
  • active bleeding
  • history of intracranial hemorrhage
  • recent gastrointestinal bleeding (within 30 days)
  • history of coagulation disorders
  • platelet count less than <100 x10^3/mcl
  • hemoglobin concentration less than 10.0 g/dl
  • history of moderate or severe hepatic impairment
  • history of major surgery or severe trauma (within 3 months)
  • patients considered by the investigator to be at risk of bradycardic events
  • second or third degree atrioventricular block during screening for eligibility
  • history of asthma or severe chronic obstructive pulmonary disease
  • patient required dialysis
  • manifest infection or inflammatory state
  • Killip class III or IV during screening for eligibility
  • respiratory failure
  • history of severe chronic heart failure (NYHA class III or IV)
  • concomitant therapy with strong CYP3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir) or strong CYP3A inducers (rifampicin, phenytoin, carbamazepine, dexamethasone, phenobarbital) within 14 days and during study treatment
  • body weight below 50 kg

Sites / Locations

  • Cardiology Department, Dr. A. Jurasz University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Morphine

Placebo

Arm Description

morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor

sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor

Outcomes

Primary Outcome Measures

Area Under the Plasma Concentration-time Curve for Ticagrelor (AUC 0-12h)
Exposure to ticagrelor during the first 12 hours after ticagrelor loading dose

Secondary Outcome Measures

Area Under the Plasma Concentration-time Curve for AR-C124910XX (AUC 0-12h)
Exposure to ticagrelor metabolite during the first 12 hours after ticagrelor loading dose
Maximum Concentration of Ticagrelor
Maximum concentration (Cmax) of ticagrelor
Maximum Concentration of AR-C124910XX
Maximum concentration (Cmax) of AR-C124910XX
Time to Maximum Concentration for Ticagrelor
Time to maximum concentration (Tmax) for ticagrelor
Time to Maximum Concentration for AR-C124910XX
Time to maximum concentration (Tmax) for AR-C124910XX
Area Under the Plasma Concentration-time Curve for Ticagrelor (AUC 0-6h)
Exposure to ticagrelor during the first 6 hours after ticagrelor loading dose
Area Under the Plasma Concentration-time Curve for AR-C124910XX (AUC 0-6)
Exposure to ticagrelor metabolite during the first 6 hours after ticagrelor loading dose
Platelet Reactivity Index Assessed by VASP Assay
Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)
Platelet Reactivity Index Assessed by VASP Assay
Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)
Platelet Reactivity Index Assessed by VASP Assay
Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)
Platelet Reactivity Index Assessed by VASP Assay
Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)
Platelet Reactivity Index Assessed by VASP Assay
Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)
Platelet Reactivity Index Assessed by VASP Assay
Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)
Platelet Reactivity Index Assessed by VASP Assay
Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)
Platelet Reactivity Index Assessed by VASP Assay
Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)
Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry
Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)
Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry
Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)
Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry
Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)
Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry
Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)
Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry
Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)
Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry
Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)
Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry
Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)
Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry
Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)
P2Y12 Reaction Units Assessed by VerifyNow
P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)
P2Y12 Reaction Units Assessed by VerifyNow
P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)
P2Y12 Reaction Units Assessed by VerifyNow
P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)
P2Y12 Reaction Units Assessed by VerifyNow
P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)
P2Y12 Reaction Units Assessed by VerifyNow
P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)
P2Y12 Reaction Units Assessed by VerifyNow
P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)
P2Y12 Reaction Units Assessed by VerifyNow
P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)
P2Y12 Reaction Units Assessed by VerifyNow
P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)
Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With VASP
Percentage of Patients With High Platelet Reactivity (HPR) After the Loading Dose of Ticagrelor Assessed With VASP
Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With MEA
Percentage of Patients With High Platelet Reactivity (HPR) After the Loading Dose of Ticagrelor Assessed With MEA
Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With VerifyNow
Percentage of Patients With High Platelet Reactivity (HPR) After the Loading Dose of Ticagrelor Assessed With VerifyNow
Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With VASP
Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity (HPR) Evaluated With VASP
Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With MEA
Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity (HPR) Evaluated With MEA
Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With VerifyNow
Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity (HPR) Evaluated With VerifyNow

Full Information

First Posted
August 14, 2014
Last Updated
August 12, 2017
Sponsor
Collegium Medicum w Bydgoszczy
search

1. Study Identification

Unique Protocol Identification Number
NCT02217878
Brief Title
Influence of Morphine on Pharmacokinetics and Pharmacodynamics of Ticagrelor in Patients With Acute Myocardial Infarction
Acronym
IMPRESSION
Official Title
A Randomized, Double-blind Study Evaluating the Influence of Morphine on Pharmacokinetics and Pharmacodynamics of Ticagrelor and Its Active Metabolite (AR-C124910XX) in Patients With ST-segment Elevation Myocardial Infarction and Non-ST-segment Elevation Myocardial Infarction.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Collegium Medicum w Bydgoszczy

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the IMPRESSION study is to determine whether intravenous administration of morphine prior to ticagrelor administration in ST-segment elevation myocardial infarction (STEMI) patients and in non-ST-segment elevation myocardial infarction (NSTEMI) patients alters the plasma concentrations of ticagrelor and its active metabolite and whether it is associated with any negative impact on the antiplatelet effect of ticagrelor.
Detailed Description
The European Society of Cardiology and American Heart Association guidelines recommend use of morphine as a treatment of choice for pain relief in STEMI patients. However, this recommendation, although strong, is only based on expert consensus (class of recommendation I, level of evidence C). Morphine, apart from its analgesic effects, also alleviates the work of breathing and reduces anxiety. On the other hand, despite its favorable analgesic and sedative actions, morphine also exerts adverse effects, which include hypotension, bradycardia, respiratory depression, vomiting and reduction of gastrointestinal motility. Some of the previously listed morphine's side effects could affect the intestinal absorption and thus pharmacokinetics and pharmacodynamics of orally administered drugs which are concomitantly used with morphine. At present, no pharmacokinetic and pharmacodynamic data regarding the concurrent use of morphine and P2Y12 blockers in the STEMI or NSTEMI setting are available. Therefore, evidence-based verification of morphine's influence on pharmacokinetics and pharmacodynamics of ticagrelor and its active metabolite (AR-C124910XX) could provide a valuable insight in the knowledge regarding modern acute myocardial infarction management. Predefined subanalysis: aimed to investigate which one of platelet reactivity assessment methods utilized in the study (VASP assay, MEA, LTA, VerifyNow) best reflects concentration of ticagrelor and its active metabolite (AR-C124910XX). Since there is no reference study examining pharmacokinetics of ticagrelor in STEMI or NSTEMI patients, we decided to perform an internal pilot study of approximately 30 patients (15 patients for each arm) for estimating the final sample size.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-segment Elevation Myocardial Infarction, Non-ST-segment Elevation Myocardial Infarction, VA Drug Interactions
Keywords
ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, ticagrelor, morphine, pharmacokinetics, pharmacodynamics, drug interactions, VASP assay, Multiple Electrode Aggregometry, VerifyNow

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Morphine
Arm Type
Active Comparator
Arm Description
morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
Morphine sulfate
Intervention Description
IV bolus injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sodium chloride 0,9%
Intervention Description
IV bolus injection
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Other Intervention Name(s)
Brilique
Intervention Description
180 mg loading dose
Primary Outcome Measure Information:
Title
Area Under the Plasma Concentration-time Curve for Ticagrelor (AUC 0-12h)
Description
Exposure to ticagrelor during the first 12 hours after ticagrelor loading dose
Time Frame
prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
Secondary Outcome Measure Information:
Title
Area Under the Plasma Concentration-time Curve for AR-C124910XX (AUC 0-12h)
Description
Exposure to ticagrelor metabolite during the first 12 hours after ticagrelor loading dose
Time Frame
prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
Title
Maximum Concentration of Ticagrelor
Description
Maximum concentration (Cmax) of ticagrelor
Time Frame
12 hours
Title
Maximum Concentration of AR-C124910XX
Description
Maximum concentration (Cmax) of AR-C124910XX
Time Frame
12 hours
Title
Time to Maximum Concentration for Ticagrelor
Description
Time to maximum concentration (Tmax) for ticagrelor
Time Frame
12 hours
Title
Time to Maximum Concentration for AR-C124910XX
Description
Time to maximum concentration (Tmax) for AR-C124910XX
Time Frame
12 hours
Title
Area Under the Plasma Concentration-time Curve for Ticagrelor (AUC 0-6h)
Description
Exposure to ticagrelor during the first 6 hours after ticagrelor loading dose
Time Frame
prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose
Title
Area Under the Plasma Concentration-time Curve for AR-C124910XX (AUC 0-6)
Description
Exposure to ticagrelor metabolite during the first 6 hours after ticagrelor loading dose
Time Frame
prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose
Title
Platelet Reactivity Index Assessed by VASP Assay
Description
Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)
Time Frame
prior to the initial ticagrelor dose
Title
Platelet Reactivity Index Assessed by VASP Assay
Description
Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)
Time Frame
30 minutes post ticagrelor dose
Title
Platelet Reactivity Index Assessed by VASP Assay
Description
Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)
Time Frame
1 hour post ticagrelor dose
Title
Platelet Reactivity Index Assessed by VASP Assay
Description
Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)
Time Frame
2 hours post ticagrelor dose
Title
Platelet Reactivity Index Assessed by VASP Assay
Description
Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)
Time Frame
3 hours post ticagrelor dose
Title
Platelet Reactivity Index Assessed by VASP Assay
Description
Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)
Time Frame
4 hours post ticagrelor dose
Title
Platelet Reactivity Index Assessed by VASP Assay
Description
Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)
Time Frame
6 hours post ticagrelor dose
Title
Platelet Reactivity Index Assessed by VASP Assay
Description
Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)
Time Frame
12 hours post ticagrelor dose
Title
Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry
Description
Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)
Time Frame
prior to the initial ticagrelor dose
Title
Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry
Description
Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)
Time Frame
30 minutes post ticagrelor dose
Title
Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry
Description
Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)
Time Frame
1 hour post ticagrelor dose
Title
Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry
Description
Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)
Time Frame
2 hours post ticagrelor dose
Title
Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry
Description
Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)
Time Frame
3 hours post ticagrelor dose
Title
Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry
Description
Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)
Time Frame
4 hours post ticagrelor dose
Title
Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry
Description
Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)
Time Frame
6 hours post ticagrelor dose
Title
Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry
Description
Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)
Time Frame
12 hours post ticagrelor dose
Title
P2Y12 Reaction Units Assessed by VerifyNow
Description
P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)
Time Frame
prior to the initial ticagrelor dose
Title
P2Y12 Reaction Units Assessed by VerifyNow
Description
P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)
Time Frame
30 minutes post ticagrelor dose
Title
P2Y12 Reaction Units Assessed by VerifyNow
Description
P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)
Time Frame
1 hour post ticagrelor dose
Title
P2Y12 Reaction Units Assessed by VerifyNow
Description
P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)
Time Frame
2 hours post ticagrelor dose
Title
P2Y12 Reaction Units Assessed by VerifyNow
Description
P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)
Time Frame
3 hours post ticagrelor dose
Title
P2Y12 Reaction Units Assessed by VerifyNow
Description
P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)
Time Frame
4 hours post ticagrelor dose
Title
P2Y12 Reaction Units Assessed by VerifyNow
Description
P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)
Time Frame
6 hours post ticagrelor dose
Title
P2Y12 Reaction Units Assessed by VerifyNow
Description
P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)
Time Frame
12 hours post ticagrelor dose
Title
Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With VASP
Description
Percentage of Patients With High Platelet Reactivity (HPR) After the Loading Dose of Ticagrelor Assessed With VASP
Time Frame
2 hours
Title
Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With MEA
Description
Percentage of Patients With High Platelet Reactivity (HPR) After the Loading Dose of Ticagrelor Assessed With MEA
Time Frame
2 hours
Title
Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With VerifyNow
Description
Percentage of Patients With High Platelet Reactivity (HPR) After the Loading Dose of Ticagrelor Assessed With VerifyNow
Time Frame
2 hours
Title
Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With VASP
Description
Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity (HPR) Evaluated With VASP
Time Frame
12 hours
Title
Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With MEA
Description
Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity (HPR) Evaluated With MEA
Time Frame
12 hours
Title
Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With VerifyNow
Description
Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity (HPR) Evaluated With VerifyNow
Time Frame
12 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: provision of informed consent prior to any study specific procedures diagnosis of acute ST-segment elevation myocardial infarction or acute non-ST-segment elevation myocardial infarction male or non-pregnant female, aged 18-80 years old provision of informed consent for angiography and PCI Exclusion Criteria: chest pain described by the patient as unbearable or patient's request for analgesics prior morphine administration during the current STEMI or NSTEMI treatment with ticlopidine, clopidogrel, prasugrel or ticagrelor within 14 days before the study enrollment hypersensitivity to ticagrelor current treatment with oral anticoagulant or chronic therapy with low-molecular-weight heparin active bleeding history of intracranial hemorrhage recent gastrointestinal bleeding (within 30 days) history of coagulation disorders platelet count less than <100 x10^3/mcl hemoglobin concentration less than 10.0 g/dl history of moderate or severe hepatic impairment history of major surgery or severe trauma (within 3 months) patients considered by the investigator to be at risk of bradycardic events second or third degree atrioventricular block during screening for eligibility history of asthma or severe chronic obstructive pulmonary disease patient required dialysis manifest infection or inflammatory state Killip class III or IV during screening for eligibility respiratory failure history of severe chronic heart failure (NYHA class III or IV) concomitant therapy with strong CYP3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir) or strong CYP3A inducers (rifampicin, phenytoin, carbamazepine, dexamethasone, phenobarbital) within 14 days and during study treatment body weight below 50 kg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Jacek Kubica, MD, PhD
Organizational Affiliation
Collegium Medicum im. Ludwika Rydygiera w Bydgoszczy, Uniwersytet Mikołaja Kopernika w Toruniu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology Department, Dr. A. Jurasz University Hospital
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-094
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26491112
Citation
Kubica J, Adamski P, Ostrowska M, Sikora J, Kubica JM, Sroka WD, Stankowska K, Buszko K, Navarese EP, Jilma B, Siller-Matula JM, Marszall MP, Rosc D, Kozinski M. Morphine delays and attenuates ticagrelor exposure and action in patients with myocardial infarction: the randomized, double-blind, placebo-controlled IMPRESSION trial. Eur Heart J. 2016 Jan 14;37(3):245-52. doi: 10.1093/eurheartj/ehv547. Epub 2015 Oct 21.
Results Reference
derived
PubMed Identifier
25925591
Citation
Kubica J, Adamski P, Ostrowska M, Kozinski M, Obonska K, Laskowska E, Obonska E, Grzesk G, Winiarski P, Paciorek P. Influence of Morphine on Pharmacokinetics and Pharmacodynamics of Ticagrelor in Patients with Acute Myocardial Infarction (IMPRESSION): study protocol for a randomized controlled trial. Trials. 2015 Apr 29;16:198. doi: 10.1186/s13063-015-0724-z.
Results Reference
derived

Learn more about this trial

Influence of Morphine on Pharmacokinetics and Pharmacodynamics of Ticagrelor in Patients With Acute Myocardial Infarction

We'll reach out to this number within 24 hrs