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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02175875
Other study ID # EudraCT nr: 2013-005529-22
Secondary ID 2013-005529-22
Status Completed
Phase N/A
First received June 25, 2014
Last updated April 6, 2016
Start date September 2014
Est. completion date October 2015

Study information

Verified date April 2016
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Health and Medicines Authority
Study type Observational

Clinical Trial Summary

The study will investigate the effect of the oral antiplatelet agent ticagrelor (Brilique) when it is administrated through a nasogastric tube in comatose patients. The platelet function can be determined by various platelet function tests (PFT), Multiplate and VerifyNow . As control, the reference intervals from the literature are used. Futhermore, plasma concentrations of the active metabolite will be determined at aeveral timepoints after first intake of a bolus dose.


Description:

Study population:

Fifty patients admitted after cardiac arrest and who have all undergone acutte PCI will be inclded in the trial.

All patients hospitalized at the cardiologic intensive department, RH, who are receiving ticagrelor (Brilique) through a nasogastric tube can be enrolled in the study. Administration of ticagrelor will follow usual indications and will thus only be used for patients considered to suffer from acute coronary syndromes (ACS). Blood samples are collected from an already inserted central venous catheter (CVC) and will therefore not affect the patients any further. The first samples will be collected directly before the first doses of medicine is given (t0), the samples are thereafter being repeatedly taken after (2(±1), 4(±1), 8(±1),12(±1), and 24(±2) hours, hereafter daily (kl. 6-8 am) until after the first day where the patient can receive tablets orally, or until intensive care treatment is terminated (though, at most 5 days of sampling, addition to the first day).

Medical treatment

All study participants will be receiving antithrombotic treatment on clinical indication: aspirin + ticagrelor (brilique), thus no antithrombotic is given without indication and doses (bolus and maintain dose) is given according to the product information. Time sets for medicine administration is controlled by the EPM (electronic patient medication module). The Ticagrelor used is "medicine-off-the-shelf" administrated in following doses:

Ticagrelor: bolus 180 mg p.o. as soon as possible after PCI and after insertion of a naso-gastic tube. Maintenance doses (90 mg) are administrated at 6 AM (+/- 1h) and 6PM (+/- 1h) with the first maintenance dose administrated < 12 hours after bolus a 6AM or 6 PM whatever comes first. Contraindications as stated in the respectively product's summary are followed.

Blood samples Blood collected for platelet function analysis are analysed immediately by VerifyNow and Multiplate and TEG-platelet mapping if available. In addition, 50 ml of blood is saved in a research bio bank for a collected analysis of concentrations of ticagrelor (active metabolite and parent compound) at the end of study. Residual blood will be destroyed. The maximum total amount of blood collected will be 150 ml.

Informed consent in a trial of in-capacitated patients In the trial, patients who all are unconscious due to prior cardiac arrest or due to cardiogenic shock are participating. Most of the patients will be connected to life support and others are in unconscious states, which exclude the possibility of obtaining an informed agreement. All patients are > 18 years old.

The study will be conducted under Danish and international guidelines for good clinical practice (ICHP-GCP) and the study are approved by the regional scientific ethical committee and the Danish Medical Agency. The participating study persons will all be unconscious, sedated or in a cerebral situation where you cannot reasonable consider involvement in a scientific study, and they are therefore not able to give informed consent in the acute phase. Current guidelines recommend acute revascularization and if necessary, circulation support and/or a cooling regimen and all treatment will be in accordance with local practice Inclusion in the project before obtaining informed consent can be justified according to the committee law's § 12. There are established a committee of two "legal guardians" (Danish: forsøgsværge), who have to agree to the patient's involvement in the trial and will make an individual judgement of the single patient's suitability to participate. The "legal guardian" (Danish: forsøgsværge) will at the time, receive the updated study protocol and all the information material which otherwise would have been presented to the patient/next of kin in the context of obtaining informed consent.

Study procedures can start after accept from the legal guardian (Danish:forsøgsværge) however subsequent informed consent from the patient's next-of-kin should be obtained as soon as possible, as well as from the patient's general practitioner/health officer.

Patients who regain their conscious will be asked for informed agreement. The agreeing part will be provided with information in word and speech regarding the study, so as the concerned will be able to make an informed decision about participation in the trial. The concerned part will be informed by the, for the study responsible, doctor or the attending doctor, who will be trained in the protocol. The declaration of consent has to be signed by the patient himself or his/her next-of-kin, as well as by the investigator who obtains the informed agreement.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date October 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 100 Years
Eligibility Inclusion criteria are for the trial are:

1. Recent (<3 hours) PCI and therefore indication for oral ADP inhibitor treatment

2. The patient is in a condition that disables normal oral administration of tablets and requires naso-gastric tube insertion.

Exclusion criteria

1. Age < 18 years old

2. Serious bleeding tendency, absolute contraindication to antithrombotic treatment (as defined in product information)

3. Pregnancy

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Rigshospitalet Copenhagen O

Sponsors (2)

Lead Sponsor Collaborator
Lene Holmvang AstraZeneca

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Plasma concentration of active drug and parent compound 2 hours to 5 days No
Primary Platelet inhibition measured by VerifyNow at 12 hours 12 hours after ticagrelor bolus No
Secondary Platelet inhibition at several time points by VerifyNow and Multiplate 2hours to 5 days after admission No
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