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.
