Platelet inhibition with cangrelor in unconcious survivors of out-of-hospital cardiac arrest undergoing cardiac artery stent implantation

Platelet inhibition with cangrelor in comatose survivors of out-of-hospital cardiac arrest undergoing primary percutaneous coronary intervention

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001285-15-SI

Enrollment

Registered

2019-03-25

Start date

2019-06-28

Completion date

Unknown

Last updated

2024-05-21

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

Conditions

Comatose survivors of out-of-hospital cardiac arrest undergoing primary percutaneous coronary intervention

Interventions

Trade Name: kangrelor 50 mg (Kangrexal) Product Name: Kangrexal Product Code: 1045926 Pharmaceutical Form: Powder for concentrate for solution for injection/infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - age 18 to 70 years - comatose survivors of out-of-hospital cardiac arrest undergoing primary percutaneous coronary intervention - treatment with induced therapeutic hypothermia - no contraindication for dual antiplatelet therapy 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 30

Exclusion criteria

Exclusion criteria: - pregnancy - patients without return of spontaneous circulation or patients on ECMO - history of recent P2Y12 use (last 7 days) - history of recent vitamin K antagonist or NOAC use (last 14 days) - active bleeding - history of transient ischemic attack or cerebral vascular insult - strong bleeding tendency (Child C liver cirrhosis, stage IV-V chronic renal disease) - history of allergic reactions to acetylsalicylic acid, heparin or P2Y12 inhibitors - terminal disease or life expectancy less than 1 year

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the trial is to find out if 4-hour continuous infusion of parenteral P2Y12 inhibitor cangrelor at the start of primary percutaneous coronary intervention immediately and effectively suppresses platelet activity in comatose survivors of out-of-hospital cardiac arrest. Treatment with cangrelor is thereby supposed to bridge the gap of suboptimal platelet inhibition after administration of crushed and dissolved ticagrelor tablets via nasogastric or orogastric tube. ;Secondary Objective: Not applicable;Primary end point(s): Primary efficacy endpoint: Platelet inhibition measured by VerifyNow and Multiplate 1, 3 and 5 hours after the start of cangrelor infusion Primary safety endpoint: Bleeding (BARC score), need for discontinuation of cangrelor infusion due to significant bleeding;Timepoint(s) of evaluation of this end point: At the start of the primary percutaneous coronary intervention cangrelor infusion will be started and 1, 3 and 5 hours after initiating the infusion blood samples will be drawn to determine platelet inhibition with VerifyNow and Multiplate methods. Safety profile will be closelly followed until the infusion will be stopped and patients will be monitored in the intensive therapy unit.	—

Measure

Time frame

Main Objective: The main objective of the trial is to find out if 4-hour continuous infusion of parenteral P2Y12 inhibitor cangrelor at the start of primary percutaneous coronary intervention immediately and effectively suppresses platelet activity in comatose survivors of out-of-hospital cardiac arrest. Treatment with cangrelor is thereby supposed to bridge the gap of suboptimal platelet inhibition after administration of crushed and dissolved ticagrelor tablets via nasogastric or orogastric tube. ;Secondary Objective: Not applicable;Primary end point(s): Primary efficacy endpoint: Platelet inhibition measured by VerifyNow and Multiplate 1, 3 and 5 hours after the start of cangrelor infusion Primary safety endpoint: Bleeding (BARC score), need for discontinuation of cangrelor infusion due to significant bleeding;Timepoint(s) of evaluation of this end point: At the start of the primary percutaneous coronary intervention cangrelor infusion will be started and 1, 3 and 5 hours after initiating the infusion blood samples will be drawn to determine platelet inhibition with VerifyNow and Multiplate methods. Safety profile will be closelly followed until the infusion will be stopped and patients will be monitored in the intensive therapy unit.

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Final angiographic result will be evaluated on the following working day after primary percutaneous coronary intervention. All other secondary endpoints will be evaluated for the time of hospital stay. ;Secondary end point(s): Secondary endpoints: Final angiographic result as evaluated by independent blinded interventional cardiologist, probable/definite stent thrombosis during hospital stay, hospital survival, hospital survival with good neurological outcome (CPC 1-2)	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Final angiographic result will be evaluated on the following working day after primary percutaneous coronary intervention. All other secondary endpoints will be evaluated for the time of hospital stay. ;Secondary end point(s): Secondary endpoints: Final angiographic result as evaluated by independent blinded interventional cardiologist, probable/definite stent thrombosis during hospital stay, hospital survival, hospital survival with good neurological outcome (CPC 1-2)

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Countries

Slovenia

Contacts

Public ContactMarko Noc

University Medical Centre Ljubljana

marko.noc@mf.uni-lj.si+38615222296

Outcome results

None listed

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