A Phase 4 interventional study of Cangrelor and Placebo in Cardiopulmonary Arrest With Successful Resuscitation, ACS - Acute Coronary Syndrome and Hypothermia, Induced, sponsored by Medical University of Vienna. Status unknown at 1 site in Austria. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2017-09-13.
Sponsored by Medical University of Vienna · Phase 4, Interventional, and Treatment
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Among 34 studies in Acute Coronary Syndrome with a site in Austria — 3 open to participants now, 4 under way, none of them phase 3. Acute Coronary Syndrome · Austria.
Among the 34 studies in Acute Coronary Syndrome with a site in Austria, this one is the 24th largest by planned enrollment of the 26 interventional ones that give a count, is the only one that started in 2017, is one of 5 in phase 4, and was the 24th registered.
1,489 studies on the registry are indexed under Acute Coronary Syndrome; 271 are open to participants now.
Browse Acute Coronary Syndrome studies →3 of the 34 studies in Acute Coronary Syndrome with a site in Austria are open now. Recruiting first, the newest first:
Medical University of Vienna · Sites in Austria
Ages 18+
Pensionsversicherungsanstalt · Sites in Austria
Ages 18+
RobotDreams GmbH · Sites in Austria
Ages 18+ · Healthy volunteers
A study can be open while its sites in Austria have not opened yet or have stopped. Only those recruiting at a site in Austria →
Of the 195 Acute Coronary Syndrome studies recruiting now, 144 (74%) set no upper age limit and 19 (10%) stop at 75 or younger; 14 take children under 18; 15 take healthy volunteers.
This study: 18 Years to 74 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
34 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is below the median of 200 across 866 interventional studies indexed under Acute Coronary Syndrome.
Median enrollment 3,271 across the 26 interventional studies, 900 across the 8 observational. Of the 27 that completed or were terminated, 12 (44%) have results posted.
This tab as a report to print or save as PDF → With an account.
18 of 34 have an industry lead sponsor. The 10 most frequent:
Medical University of Vienna is the lead sponsor of 1,109 studies on the registry; 184 are open to participants now.
Medical University of Vienna has 6 studies filed under Acute Coronary Syndrome — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 34 studies in Acute Coronary Syndrome with a site in Austria, from their registry updates:
This tab as a report to print or save as PDF → With an account.
In patients with ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary angioplasty (PCI) P2Y12 receptor (P2Y12r) inhibition should be achieved as soon as possible. Resuscitated STEMI-patients receiving targeted temperature management (TTM, therapeutic hypothermia) after cardiac arrest, however, show deteriorated and delayed early response to available oral P2Y12r inhibitors. Therapeutic hypothermia attenuates the drugs' effectiveness by reducing its gastrointestinal absorption and metabolic activation. Acute stent thrombosis is 5-fold increased after angioplasty following resuscitated cardiac arrest because of insufficient early platelet suppression. Thus, aggressive antiplatelet strategies are needed to achieve optimal platelet suppression during PCI in those patients. The first intravenous P2Y12r inhibitor, cangrelor, has recently received marketing authorization for the acute treatment of STEMI. We hypothesize that add-on antiplatelet therapy with intravenous Cangrelor on-top of standard dual anti platelet therapy (DAPT) with Prasugrel or Ticagrelor is superior to standard antiplatelet therapy alone in terms of suppressing ADP-dependent platelet activation in resuscitated STEMI-patients receiving TTM.
Neurologic damage after cardiac arrest is frequent and therapeutic options to improve neurological outcome are limited. Treatment by therapeutic hypothermia (TH, 32-34◦C) for 12-24 h showed improved neurological outcome in several trials. Therefore, international guidelines recommend targeted temperature management (TTM) to 32-34◦C (or at least 36°C) for 12-24 h, especially when the initial rhythm was ventricular fibrillation.
However, patients treated with TTM after cardiac arrest show deteriorated and delayed response to P2Y12 receptor (P2Y12r) inhibitors as determined by platelet reactivity index vasodilator-stimulated phosphoprotein phosphorylation (PRI VASP) after administration of the loading dose of clopidogrel, prasugrel and ticagrelor. Especially the response to clopidogrel is poor with up to >80% non-responder after 24 hours. Impaired P2Y12r blockade may lead to acute stent-thrombosis and trigger overall adverse outcome.
There are several explanations for the impaired efficacy of P2Y12r inhibitors in cardiac arrest patients. First, marketed oral P2Y12r inhibitors have to be applied in crushed form via nasogastric tube in comatose post cardiac arrest patients. Placement of nasogastric tube and crushing may delay onset of therapy. Second, drug uptake and bioavailability of oral P2Y12r inhibitors are dependent on gastric motility and sufficient splanchnic blood supply, which is affected by TTM, acute critical illness (shock) and concomitant therapy. Particularly, sedation and analgesic agents, especially concomitant morphine therapy, can hamper gastric emptying. Various recent trials demonstrated that morphine administration delays and attenuates clopidogrel, prasugrel and ticagrelor exposure and action in healthy subjects and patients with myocardial infarction.
The recently authorized parenteral cangrelor is an adenosine triphosphate (ATP) analogue that binds reversibly and with high affinity to the platelet P2Y12r. It induces a highly effective inhibition of ADP-induced platelet aggregation immediately after intravenous (iv) bolus administration and allows for restoration of platelet function within 1-2 h of infusion discontinuation. The pharmacokinetic properties known so far suggest cangrelor being the "ideal" P2Y12r inhibitor for patients with cardiac-ischemia triggered OHCA treated with TH and may overcome the impaired and delayed P2Y12r blockade seen with the oral P2Y12r inhibitors.
Cardiac arrest is a leading cause of death among adults over the age of 40 in the European Union (EU) and other western countries. In the EU alone, more than 400.000 people of all ages experience EMS-assessed out-of-hospital non-traumatic cardiac arrest each year and most of them die. In a large proportion of these patients (about 50%) an acute coronary syndrome (ACS), mainly acute ST-elevation myocardial infarction, leading to ventricular fibrillation and cardiac standstill is the cause of the cardiac arrest. Various trials demonstrated that early cardiac intervention including stent placement to the culprit lesion improves outcome in this patient group. The P2Y12r plays a central role in platelet activation and P2Y12r inhibitors are part of standard care in patients with ACS. Delayed and insufficient P2Y12r inhibition may predispose to acute stent thrombosis with potential devastating effects including cardiogenic shock, re-arrest and death. Given the deteriorated and delayed response to oral P2Y12r inhibitors in cardiac arrest patients treated with TH, clinical evaluation of the recently marketed parenteral P2Y12r inhibitor cangrelor is mandatory in this patient group.
To determine the effect of add-on cangrelor in STEMI-associated out-of-hospital cardiac arrest (OHCA) who receive TTM and are scheduled for PCI, a phase 4 trial will be conducted.The trial consists of 2 parts. Part A (n=12, 8months duration): An open-fashioned pilot safety-study to ensure sufficient platelet suppression (\<466AU*min, impedance aggregometry) over 24 hours after concurrent cangrelor-prasugrel/ticagrelor administration. The aim is to determine pharmacokinetics and -dynamics of oral P2Y12r-inhibitors with and without concomitant administration of cangrelor. Part B (n=48, 32months duration): A factorial randomized, placebo-controlled, double-blind study with 4 study cohorts enrolling 48 patients who will first be randomised to receive prasugrel (n=24) or ticagrelor (n=24) and secondly to additionally receive cangrelor or placebo (sterile saline). Primary endpoint: ADP-dependent platelet reactivity at time of stent placement (AU*min). Student's t-test to test H0 (no difference in AU*min, cangrelor vs placebo).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
If eligible, assigned to this arm and without contraindications to prasugrel administration, patients will receive a loading dose of prasugrel (60 mg) via nasogastric tube as soon as possible after arrival at the emergency department. Afterwards a 30 micrograms (mcg)/kg iv bolus of cangrelor followed immediately by a 4 mcg/kg/min iv infusion (lasting for at least 2 hours or for the duration of the revascularization procedure, whichever is longer) will be administered.
Drug: Cangrelor · Drug: Prasugrel
If eligible and assigned to this arm (i.e. patients who have contraindications against prasugrel (age \>75years, weight \<60kg, history of transient ischemic attack, ischemic stroke, intracranial bleeding, known allergy against prasugrel/Efient), patients will receive a loading dose of ticagrelor (180 mg) via nasogastric tube as soon as possible after arrival at the emergency department. Afterwards a 30 micrograms (mcg)/kg iv bolus of cangrelor followed immediately by a 4 mcg/kg/min iv infusion (lasting for at least 2 hours or for the duration of the revascularization procedure, whichever is longer) will be administered.
Drug: Cangrelor · Drug: Ticagrelor
If eligible, assigned to this arm and no contraindications to prasugrel, patients will receive a loading dose of prasugrel (60 mg) via nasogastric tube as soon as possible after arrival at the emergency department. Afterwards a 30 micrograms (mcg)/kg iv bolus of placebo (0.9% NaCl) followed immediately by a 4 mcg/kg/min iv infusion of placebo (0.9% NaCl) (lasting for at least 2 hours or for the duration of the revascularization procedure, whichever is longer) will be administered.
Drug: Placebo · Drug: Prasugrel
If eligible and assigned to this arm (i.e. patients who have contraindications against prasugrel (age \>75years, weight \<60kg, history of transient ischemic attack, ischemic stroke, intracranial bleeding, known allergy against prasugrel/Efient), patients will receive a loading dose of ticagrelor (180 mg) via nasogastric tube as soon as possible after arrival at the emergency department. Afterwards a 30 micrograms (mcg)/kg iv bolus of placebo (0.9% NaCl) followed immediately by a 4 mcg/kg/min iv infusion placebo (0.9% NaCl) (lasting for at least 2 hours or for the duration of the revascularization procedure, whichever is longer) will be administered.
Drug: Placebo · Drug: Ticagrelor
The intervention comprises add-on Cangrelor infusion (administration in compliance with manufacturer instructions) in addition to and after administration of standard P2Y12-blocker (prasugrel or ticagrelor) therapy.
The intervention comprises add-on placebo infusion (0.9% NaCl) in addition to and after administration of standard P2Y12-blocker (prasugrel or ticagrelor) therapy as placebo comparator
Also known as: 0.9% NaCl
The intervention comprises the standard P2Y12-blocker prasugrel therapy if not contraindicated.
The intervention comprises the standard P2Y12-blocker ticagrelor therapy if prasugrel is contraindicated and no contraindication to ticagrelor is present.
Platelet reactivity at stent placement
Platelet reactivity (ADP-dependent platelet inhibition) at the time of cardiac intervention (i.e. at the time of stent placement) measured by impedance aggregometry (Multiplate Analyzer; aggregation units/min, AU\*min)
Time frame: up to 4 hours; time from study drug administration (Cangrelor/Placebo) to stent placement
Platelet reactivity
Platelet reactivity at baseline, 15 minutes, 30 minutes, 60minutes, 120 minutes, 240 minutes and 12 hours after study drug administration (Multiplate Analyzer, AU\*min; VASP assay, platelet reactivity units PRU; PFA-100, closure time, CT).
Time frame: 15 minutes, 30 minutes, 60 minutes, 120 minutes, 240 minutes, 12hours from administration of study drug.
Platelet inhibition
Onset of ADP-dependent platelet inhibition (Multiplate Analyzer, VASP assay, PFA-100).
Time frame: 15 minutes, 30 minutes, 60 minutes, 120 minutes, 240 minutes, 12hours from administration of study drug.
Maximum Plasma Concentration [Cmax]
Prasugrel/Ticagrelor/Cangrelor metabolites will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS) at the time of stent placement, 15minutes, 30 minutes, 60 minutes, 120 minutes, 240 minutes and 12 hours after study drug administration
Time frame: 15 minutes, 30 minutes, 60 minutes, 120 minutes, 240 minutes, 12hours from administration of study drug.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2017; primary completion for May 2021, 44 months later.
Of 85 non-industry phase 4 interventional studies under Acute Coronary Syndrome, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 67. This study's planned 44 months is close to that.
Counting every sponsor, half of 92 studies reached it within 42 months; a quarter within 26 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cangrelor
Medical University of Vienna →