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Platelet inhibition in comatose patients receiving oral anti platelet therapy through a naso-gastric tube after undergoing acute percutaneous coronary intervention

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005529-22-DK

Enrollment

Registered

2014-02-12

Start date

2014-03-21

Completion date

Unknown

Last updated

2016-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients surviving cardiac arrest and undergoing percutaneous coronary intervention MedDRA version: 16.1 Level: LLT Classification code 10067273 Term: Acute transmural myocardial infarction System Organ Class: 100000004849 MedDRA version: 16.1 Level: LLT Classification code 10064347 Term: Non ST segment elevation myocardial infarction System Organ Class: 100000004849

Interventions

Trade Name: Plavix Pharmaceutical Form: Tablet INN or Proposed INN: Clopidogrel Other descriptive name: CLOPIDOGREL SULFATE Concentration unit: mg milligram(s) Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Cardiac arrest, recent PCI and need for oral antithrombotic treatment through a nasogastric tube. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Ongoing bleeding. Pregnancy No need (byclinical indication) for oral antithrombotic treatment

Design outcomes

Primary

Measure	Time frame
Main Objective: To describe the occurrence of ADP receptor inhibitor low responsiveness at 12 hours after administration of ADP-inhibitor by several platelet inhibitors tests (TEG, Multiplate heparin/hirudin and Verify now) ;Secondary Objective: Based on frequent blood samples to describe the time of onset of platelet inhibitions compared with data from the literature and recommendations from a consensus document on platelet function testing. ;Primary end point(s): platelet inhibition by multiplate, verifyNow and TEG;Timepoint(s) of evaluation of this end point: simultaneously (blood analyses)	—

Measure

Time frame

Main Objective: To describe the occurrence of ADP receptor inhibitor low responsiveness at 12 hours after administration of ADP-inhibitor by several platelet inhibitors tests (TEG, Multiplate heparin/hirudin and Verify now) ;Secondary Objective: Based on frequent blood samples to describe the time of onset of platelet inhibitions compared with data from the literature and recommendations from a consensus document on platelet function testing. ;Primary end point(s): platelet inhibition by multiplate, verifyNow and TEG;Timepoint(s) of evaluation of this end point: simultaneously (blood analyses)

—

Secondary

Measure	Time frame
Secondary end point(s): platelet inhibition at 12 h after bolus treatment;Timepoint(s) of evaluation of this end point: simultaneouly (blood analysis)	—

Countries

Denmark

Contacts

Public ContactLene Holmvang

Rigshospitalet

+4535451197

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026