Out-Of-Hospital Cardiac ArrestPhase 4Cangrelor OHCANCT04005729

Cangrelor in Comatose Survivors of OHCA Undergoing Primary PCI

A Phase 4 study testing Cangrelor 50 MG in people with Out-Of-Hospital Cardiac Arrest and Acute Coronary Syndrome, run by University Medical Centre Ljubljana at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Out-Of-Hospital Cardiac Arrest, Acute Coronary Syndrome
What is being tested?: Cangrelor 50 MG
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteSlovenia
Study dates: 1 Jul 2019to 27 Nov 2021
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

Slovenia1 site

University Medical Centre Ljubljana
Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: Platelet Inhibition With Cangrelor in Comatose Survivors of Out-of-hospital Cardiac Arrest Undergoing Primary Percutaneous Coronary Intervention

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 (PCI) immediately and effectively suppresses platelet activity in comatose survivors of out-of-hospital cardiac arrest (OHCA). Half of the participants will receive the standard care of dual antiplatelet therapy - acetysalicylic acid and ticagrelor tablets via nasogastric or orogastric tube and the other half the standard care with additional cangrelor infusion at the start of the PCI.

Read the detailed description

Coronary artery disease is an important cause of out-of hospital cardiac arrest (OHCA) and around 80 % of patients after OHCA are comatose. Considering patient's history, details concerning OHCA and ECG changes the decision on urgent cardiac catheterization is made. In case of significant coronary artery stenosis/occlusion on primary percutaneous coronary intervention stent implantation is usually needed. Dual antiplatelet therapy is the cornerstone of stent thrombosis prevention. Patients who are comatose after the return of spontaneous circulation (ROSC) differ from conscious survivors of OHCA because they are not able to take antiplatelet drugs, such as P2Y12 inhibitors, orally. Due to the need for nasogastric/ orogastric tube insertion there is a significant delay until optimal antiplatelet effect is achieved. Furthermore, there are other factors that have an impact on the pharmacokinetics of P2Y12 inhibitors, such as therapeutic hypothermia, gastroparesis, gastrointestinal tract hypoperfusion and platelet hyperreactivity because of systemic inflammatory response syndrome. These characteristics make acute and subacute stent thrombosis more common in comatose OHCA survivors leading to increased morbidity and mortality.

Heparin is the primary anticoagulant drug for comatose patients after OHCA. Antiplatelet therapy consists of intravenous aspirin and P2Y12 inhibitor. Ticagrelor is the most potent of the latter. It is available only as a tablet, which has to be crushed and dissolved and then given via nasogastric or orogastric tube. A recent study by Steblovnik et al. has shown there is an approximately 4-hour gap of inadequate platelet inhibition in comatose OHCA even if the most potent P2Y12 inhibitor ticagrelor is used. Prueller made a retrospective study assessing the addition of intravenous P2Y12 inhibitor cangrelor as a bridge of this gap to standard care. The results showed there is a significant antiplatelet effect when using cangrelor with no added bleeding risk. After literature review no prospective randomised study has been done comparing cangrelor-bridge to standard care with dual antiplatelet therapy (aspirin and ticagrelor).

The investigator's study is a single-blinded, prospective randomised study taking place at University Medical Centre Ljubljana. Thirty comatose survivors of OHCA will be randomised at the start of primary PCI into a test and control group. The control group will receive standard care with intravenous aspirin and dissolved ticagrelor tablets given via enteral tube. The test group patients will receive an additional P2Y12 bridging therapy: a bolus of cangrelor at the start of the PCI (30 mcg/kg) followed by a continuous 4-hour infusion (4 mcg/kg/min). Heparin will be used as per guidelines for a target ACT of 250-300 seconds at the time of PCI. Interventional cardiologist will decide on the use of eptifibatide (GP IIb/IIIa antagonist). Therapeutic hypothermia will be started in the catheterisation laboratory. All patients will be transferred to ICU after the procedure and level of platelet inhibition will be tested 1, 3 and 5 hours after the start of cangrelor infusion with VerifyNow and Multiplate systems. In the control group blood will be drawn at the same time intervals. Further management of patients in both arms will be no different from regular care.

Conditions: Out-Of-Hospital Cardiac Arrest, Acute Coronary Syndrome
Being tested: Cangrelor 50 MG
Keywords: cangrelor, P2Y12, out-of-hospital cardiac arrest, induced hypothermia, primary percutaneous coronary intervention
Medical subject headings: Out-of-Hospital Cardiac Arrest, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cangrelor 50 MGDrug
Also called Kengrexal 50 mg
30 mcg/kg bolus, then 4h infusion 4 mcg/kg/min

Study groups in NCT04005729
Study group	Role	What they receive
Cangrelor + Ticagrelor	Experimental	Bolus of cangrelor (30 mcg/kg) and immediately afterwards a continuous intravenous infusion of 4 mcg/kg/min at the start of the primary percutaneous coronary intervention. Crushed and dissolved ticagrelor tablets (180 mg) will be given via inserted enteral tube. Receives: Drug: Cangrelor 50 MG
Ticagrelor	No intervention	Crushed and dissolved ticagrelor tablets (180 mg) will be given via enteral tube (standard care).

What is being measured

The primary outcome is the main question the study is designed to answer.

VerifyNow P2Y12Test - Platelet Reactivity
Platelet inhibition measured by VerifyNow as P2Y12 reaction units (PRU). Platelet reactivity reflects P2Y12 inhibitor effect with higher PRU values showing low P2Y12 response and lower values decreased platelet reactivity due to the effect of a P2Y12 inhibitor. High on-treatment platelet reactivity was defined as >208 PRU.
Measured: 1 hour after the start of cangrelor infusion/1 hour after the start of PPCI in controls
VerifyNow P2Y12Test - Platelet Reactivity
Platelet inhibition measured by VerifyNow as P2Y12 reaction units (PRU). Platelet reactivity reflects P2Y12 inhibitor effect with higher PRU values showing low P2Y12 response and lower values decreased platelet reactivity due to the effect of a P2Y12 inhibitor. High on-treatment platelet reactivity was defined as >208 PRU.
Measured: 3 hours after the start of cangrelor infusion/3 hours after the start of PPCI in controls
VerifyNow P2Y12Test - Platelet Reactivity
Platelet inhibition measured by VerifyNow as P2Y12 reaction units (PRU). Platelet reactivity reflects P2Y12 inhibitor effect with higher PRU values showing low P2Y12 response and lower values decreased platelet reactivity due to the effect of a P2Y12 inhibitor. High on-treatment platelet reactivity was defined as >208 PRU.
Measured: 5 hours after the start of cangrelor infusion/5 hours after the start of PPCI in controls
Multiplate ADP test
Platelet activation by adenosine diphosphate (ADP) expressed in arbitrary aggregation units (U). P2Y12 inhibitors block ADP receptors and decrease platelet activation by ADP. Higher values mean less effect of P2Y12 inhibitors, lower values mean more effect of P2Y12 inhibitors on platelets. High on-treatment platelet reactivity was defined as >46 U.
Measured: 1 hour after the start of cangrelor infusion/1 hour after the start of PPCI in controls
Multiplate ADP test
Platelet activation by adenosine diphosphate (ADP) expressed in arbitrary aggregation units (U). P2Y12 inhibitors block ADP receptors and decrease platelet activation by ADP. Higher values mean less effect of P2Y12 inhibitors, lower values mean more effect of P2Y12 inhibitors on platelets. High on-treatment platelet reactivity was defined as >46 U.
Measured: 3 hours after the start of cangrelor infusion/3 hours after the start of PPCI in controls
Multiplate ADP test
Platelet activation by adenosine diphosphate (ADP) expressed in arbitrary aggregation units (U). P2Y12 inhibitors block ADP receptors and decrease platelet activation by ADP. Higher values mean less effect of P2Y12 inhibitors, lower values mean more effect of P2Y12 inhibitors on platelets. High on-treatment platelet reactivity was defined as >46 U.
Measured: 5 hours after the start of cangrelor infusion/5 hours after the start of PPCI in controls
BARC score or the need for discontinuation of cangrelor infusion
Standardized bleeding definition as described by Bleeding Academic Research Consortium (BARC).
Type 0: no bleeding.
1. actionable bleeding, does not require treatment by attending physician.
2. any overt, actionable sign of hemorrhage plus at least one criteria: (1) requiring nonsurgical, medical intervention, (2) leading to increased level of care, or (3) prompting evaluation.
3. overt bleeding plus (1) haemoglobin drop of more than 3 g/dL or need for transfusion, (2) cardiac tamponade, (3) requiring surgical intervention, (4) intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal), (5) intraocular bleed compromising vision.
4. CABG-related bleeding (not applicable).
5. Fatal bleeding: (1) probable - clinically suspicious, (2) definite - overt bleeding or autopsy or imaging confirmation.
Significant bleeding will be defined as BARC 2, 3 and 5 or the need for discontinuation of cangrelor infusion.
Measured: During the cangrelor infusion and up to 5 hours after the PCI

Secondary outcomes (5)

Angiographic result - final TIMI flow
Final angiographic result as evaluated by independent blinded interventional cardiologist. Defined as thrombolysis in myocardial infarction (TIMI) flow at the end of the procedure.
TIMI 0 flow - absence of any antegrade flow beyond a coronary occlusion TIMI 1 flow - faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed TIMI 2 flow - delayed or sluggish antegrade flow with complete filling of the distal territory TIMI 3 flow - normal flow filling the distal coronary bed completely
Residual thrombus or peripheral embolization will also be noted.
Measured: Angiography review within 24 hours of P-PCI (the following day)
Rate of stent thrombosis
Probable or definitive stent thrombosis according to Academic Research Consortium classification (ARC) of stent thrombosis.
Definite stent thrombosis - confirmed at angiography or autopsy. Probable stent thrombosis - unexplained death within 30 days after P-PCI or new myocardial infarction in P-PCI vessel territory.
Measured: During index patient hospitalization (at discharge from the hospital, up to 30 days)
Timing of stent thrombosis
Probable or definitive stent thrombosis according to Academic Research Consortium classification (ARC) of stent thrombosis based on timing of events.
Acute stent thrombosis 0-24 hours after stent implantation Subacute stent thrombosis 24 hours to 30 days after stent implantation
Measured: During index patient hospitalization (at discharge from the hospital, up to 30 days)
Survival
Survival to discharge from hospital.
Measured: During index hospitalization (at discharge from the hospital, up to 90 days)
Survival (CPC)
Survival to discharge from hospital defined as Cerebral performance category (CPC).
CPC 1 - good cerebral performance (normal life). Conscious, alert, able to work and lead a normal life.
CPC 2 - moderate cerebral disability (disabled but independent) CPC 3 - severe cerebral disability (conscious but disabled and dependent) CPC 4 - coma or vegetative state (unconscious) CPC 5 - brain death
Measured: During index hospitalization (at discharge from the hospital, up to 90 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201927 Nov 2021

First posted2 Jul 2019
Study start1 Jul 2019
Primary completion27 Nov 2021
Study completion27 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04005729
Sponsor's protocol ID: KOIIM-2019-1
Acronym: Cangrelor OHCA
Status last verified: Dec 2021
First submitted: 1 Apr 2019
Last updated: 3 Dec 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Radsel P, Knafelj R, Kocjancic S, Noc M. Angiographic characteristics of coronary disease and postresuscitation electrocardiograms in patients with aborted cardiac arrest outside a hospital. Am J Cardiol. 2011 Sep 1;108(5):634-8. doi: 10.1016/j.amjcard.2011.04.008. Epub 2011 Jun 14.
PubMed 21676367
Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
PubMed 28886621
Hogberg C, Erlinge D, Braun OO. Mild hypothermia does not attenuate platelet aggregation and may even increase ADP-stimulated platelet aggregation after clopidogrel treatment. Thromb J. 2009 Feb 23;7:2. doi: 10.1186/1477-9560-7-2.
PubMed 19236702
Steblovnik K, Blinc A, Mijovski MB, Fister M, Mikuz U, Noc M. Ticagrelor Versus Clopidogrel in Comatose Survivors of Out-of-Hospital Cardiac Arrest Undergoing Percutaneous Coronary Intervention and Hypothermia: A Randomized Study. Circulation. 2016 Dec 20;134(25):2128-2130. doi: 10.1161/CIRCULATIONAHA.116.024872. No abstract available.
PubMed 27994027
Llitjos JF, Sideris G, Voicu S, Bal Dit Sollier C, Deye N, Megarbane B, Drouet L, Henry P, Dillinger JG. Impaired biological response to aspirin in therapeutic hypothermia comatose patients resuscitated from out-of-hospital cardiac arrest. Resuscitation. 2016 Aug;105:16-21. doi: 10.1016/j.resuscitation.2016.04.027. Epub 2016 May 17.
PubMed 27224446
Pruller F, Bis L, Milke OL, Fruhwald F, Patzold S, Altmanninger-Sock S, Siller-Matula J, von Lewinski F, Ablasser K, Sacherer M, von Lewinski D. Cangrelor Induces More Potent Platelet Inhibition without Increasing Bleeding in Resuscitated Patients. J Clin Med. 2018 Nov 15;7(11):442. doi: 10.3390/jcm7110442.
PubMed 30445678
Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.
PubMed 21670242
Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51. doi: 10.1161/CIRCULATIONAHA.106.685313.
PubMed 17470709

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Platelet Inhibition With Cangrelor in Comatose Survivors of Out-of-hospital Cardiac Arrest Undergoing Primary Percutaneous Coronary Intervention
ClinicalTrials.gov ID: NCT04005729
Acronym / sponsor ID: Cangrelor OHCA / KOIIM-2019-1
Conditions: Out-Of-Hospital Cardiac Arrest, Acute Coronary Syndrome
Keywords: cangrelor, P2Y12, out-of-hospital cardiac arrest, induced hypothermia, primary percutaneous coronary intervention
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: University Medical Centre LjubljanaUniversity, hospital or other
Collaborators: Chiesi Slovenija, d.o.o.
Study start: 1 Jul 2019 (actual)
Primary completion: 27 Nov 2021 (actual)
Study completion: 27 Nov 2021 (actual)
First posted: 2 Jul 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Cangrelor + Ticagrelor	Experimental	Drug: Cangrelor 50 MGBolus of cangrelor (30 mcg/kg) and immediately afterwards a continuous intravenous infusion of 4 mcg/kg/min at the start of the primary percutaneous coronary intervention. Crushed and dissolved ticagrelor tablets (180 mg) will be given via inserted enteral tube.
Ticagrelor	No intervention	–Crushed and dissolved ticagrelor tablets (180 mg) will be given via enteral tube (standard care).

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cangrelor 50 MGAlso: Kengrexal 50 mg30 mcg/kg bolus, then 4h infusion 4 mcg/kg/min	Drug	Cangrelor + Ticagrelor

Primary outcome

VerifyNow P2Y12Test - Platelet Reactivity
Time frame: 1 hour after the start of cangrelor infusion/1 hour after the start of PPCI in controls
Platelet inhibition measured by VerifyNow as P2Y12 reaction units (PRU). Platelet reactivity reflects P2Y12 inhibitor effect with higher PRU values showing low P2Y12 response and lower values decreased platelet reactivity due to the effect of a P2Y12 inhibitor. High on-treatment platelet reactivity was defined as >208 PRU.
VerifyNow P2Y12Test - Platelet Reactivity
Time frame: 3 hours after the start of cangrelor infusion/3 hours after the start of PPCI in controls
Platelet inhibition measured by VerifyNow as P2Y12 reaction units (PRU). Platelet reactivity reflects P2Y12 inhibitor effect with higher PRU values showing low P2Y12 response and lower values decreased platelet reactivity due to the effect of a P2Y12 inhibitor. High on-treatment platelet reactivity was defined as >208 PRU.
VerifyNow P2Y12Test - Platelet Reactivity
Time frame: 5 hours after the start of cangrelor infusion/5 hours after the start of PPCI in controls
Platelet inhibition measured by VerifyNow as P2Y12 reaction units (PRU). Platelet reactivity reflects P2Y12 inhibitor effect with higher PRU values showing low P2Y12 response and lower values decreased platelet reactivity due to the effect of a P2Y12 inhibitor. High on-treatment platelet reactivity was defined as >208 PRU.
Multiplate ADP test
Time frame: 1 hour after the start of cangrelor infusion/1 hour after the start of PPCI in controls
Platelet activation by adenosine diphosphate (ADP) expressed in arbitrary aggregation units (U). P2Y12 inhibitors block ADP receptors and decrease platelet activation by ADP. Higher values mean less effect of P2Y12 inhibitors, lower values mean more effect of P2Y12 inhibitors on platelets. High on-treatment platelet reactivity was defined as >46 U.
Multiplate ADP test
Time frame: 3 hours after the start of cangrelor infusion/3 hours after the start of PPCI in controls
Platelet activation by adenosine diphosphate (ADP) expressed in arbitrary aggregation units (U). P2Y12 inhibitors block ADP receptors and decrease platelet activation by ADP. Higher values mean less effect of P2Y12 inhibitors, lower values mean more effect of P2Y12 inhibitors on platelets. High on-treatment platelet reactivity was defined as >46 U.
Multiplate ADP test
Time frame: 5 hours after the start of cangrelor infusion/5 hours after the start of PPCI in controls
Platelet activation by adenosine diphosphate (ADP) expressed in arbitrary aggregation units (U). P2Y12 inhibitors block ADP receptors and decrease platelet activation by ADP. Higher values mean less effect of P2Y12 inhibitors, lower values mean more effect of P2Y12 inhibitors on platelets. High on-treatment platelet reactivity was defined as >46 U.
BARC score or the need for discontinuation of cangrelor infusion
Time frame: During the cangrelor infusion and up to 5 hours after the PCI
Standardized bleeding definition as described by Bleeding Academic Research Consortium (BARC). Type 0: no bleeding. 1. actionable bleeding, does not require treatment by attending physician. 2. any overt, actionable sign of hemorrhage plus at least one criteria: (1) requiring nonsurgical, medical intervention, (2) leading to increased level of care, or (3) prompting evaluation. 3. overt bleeding plus (1) haemoglobin drop of more than 3 g/dL or need for transfusion, (2) cardiac tamponade, (3) requiring surgical intervention, (4) intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal), (5) intraocular bleed compromising vision. 4. CABG-related bleeding (not applicable). 5. Fatal bleeding: (1) probable - clinically suspicious, (2) definite - overt bleeding or autopsy or imaging confirmation. Significant bleeding will be defined as BARC 2, 3 and 5 or the need for discontinuation of cangrelor infusion.

5 secondary outcomes

Angiographic result - final TIMI flow
Time frame: Angiography review within 24 hours of P-PCI (the following day)
Rate of stent thrombosis
Time frame: During index patient hospitalization (at discharge from the hospital, up to 30 days)
Timing of stent thrombosis
Time frame: During index patient hospitalization (at discharge from the hospital, up to 30 days)
Survival
Time frame: During index hospitalization (at discharge from the hospital, up to 90 days)
Survival (CPC)
Time frame: During index hospitalization (at discharge from the hospital, up to 90 days)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
Background: PubMed 21676367Radsel P, Knafelj R, Kocjancic S, Noc M. Angiographic characteristics of coronary disease and postresuscitation electrocardiograms in patients with aborted cardiac arrest outside a hospital. Am J Cardiol. 2011 Sep 1;108(5):634-8. doi: 10.1016/j.amjcard.2011.04.008. Epub 2011 Jun 14.
Background: PubMed 28886621Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
Background: PubMed 19236702Hogberg C, Erlinge D, Braun OO. Mild hypothermia does not attenuate platelet aggregation and may even increase ADP-stimulated platelet aggregation after clopidogrel treatment. Thromb J. 2009 Feb 23;7:2. doi: 10.1186/1477-9560-7-2.
Background: PubMed 27994027Steblovnik K, Blinc A, Mijovski MB, Fister M, Mikuz U, Noc M. Ticagrelor Versus Clopidogrel in Comatose Survivors of Out-of-Hospital Cardiac Arrest Undergoing Percutaneous Coronary Intervention and Hypothermia: A Randomized Study. Circulation. 2016 Dec 20;134(25):2128-2130. doi: 10.1161/CIRCULATIONAHA.116.024872. No abstract available.
Background: PubMed 27224446Llitjos JF, Sideris G, Voicu S, Bal Dit Sollier C, Deye N, Megarbane B, Drouet L, Henry P, Dillinger JG. Impaired biological response to aspirin in therapeutic hypothermia comatose patients resuscitated from out-of-hospital cardiac arrest. Resuscitation. 2016 Aug;105:16-21. doi: 10.1016/j.resuscitation.2016.04.027. Epub 2016 May 17.
Background: PubMed 30445678Pruller F, Bis L, Milke OL, Fruhwald F, Patzold S, Altmanninger-Sock S, Siller-Matula J, von Lewinski F, Ablasser K, Sacherer M, von Lewinski D. Cangrelor Induces More Potent Platelet Inhibition without Increasing Bleeding in Resuscitated Patients. J Clin Med. 2018 Nov 15;7(11):442. doi: 10.3390/jcm7110442.
Background: PubMed 21670242Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.
Background: PubMed 17470709Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51. doi: 10.1161/CIRCULATIONAHA.106.685313.
Individual participant dataSharing planned: No

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Out-of-hospital Cardiac Arrest (OHCA)
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marko Noc, MD PhD principal investigator

University Medical Centre Ljubljana

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cangrelor 50 MG in people with Out-Of-Hospital Cardiac Arrest and Acute Coronary Syndrome, run by University Medical Centre Ljubljana at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VerifyNow P2Y12Test - Platelet Reactivity (time frame: 1 hour after the start of cangrelor infusion/1 hour after the start of PPCI in controls). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04005729, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.