Ticagrelor for the Comatose

NCT ID: NCT02175875

Last Updated: 2016-04-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 47 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-10-31

Brief 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.

Detailed 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.

Conditions

Comatose

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

comatose patients

180 mg ticagrelor followed by 90 mg BID for comatose patients after cardiac arrest

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Lene Holmvang

OTHER

Sponsor Role: lead

Responsible Party

Lene Holmvang

MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lene Holmvang, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Rigshospitalet

Copenhagen O, , Denmark

Countries

Denmark

Other Identifiers

2013-005529-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EudraCT nr: 2013-005529-22

Identifier Type: -

Identifier Source: org_study_id