A randomized, pharmacodynamic study of cangrelor administration in STEMI patients loaded with ticagrelor
- Conditions
- In the present study, in STEMI patients undergoing primary PCI we aim therefore to compare platelet inhibition achieved in patients loaded with ticagrelor followed by cangrelor (bolus plus infusion) vs ticagrelor alone loaded patients.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2016-002586-64-GR
- Lead Sponsor
- ELKE University of Athens
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
For patients included in the study must meet the following criteria:
1. Provide signed inform consent form for any procedure that involves the study
2. Patients with STEMI (ST segment elevation in at least two leads,> 2mm the precordial or> 1mm in inferior leads and new or suspected new-onset LBBB) who are going to perform primary angioplasty
3. Not receiving inhibitor of P2Y12 receptor
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
Patients will be excluded from the study if they met any of you following exclusion criteria:
1. Known hypersensitivity reaction to tikagkrelor or kangkrelor or to any of excipients.
2. Haemorrhagic diathesis: active pathological bleeding, serious hemorrhagic disorder, history of stroke or intracranial hemorrhage, mass lesion of the CNS or intracranial vascular disorder. Also gastro-intestinal bleeding within the last 6 months or major surgery in the last 30 days
3. Chronic anticoagulant therapy,
4. Recent angioplasty or coronary bypass surgery <3 months, low platelet count <100 000 / L,
5. Hematocrit <30%
6. creatinine clearance <30mL / min,
7. Severe hepatic dysfunction,
8. Use of potent inhibitors (amiodarone, erythromycin, fluconazole, miconazole, diltiazem, verapamil, delavirdine, amprenavir, fosamprenavir, conivaptan, clarithromycin, itraconazole, ketoconazole) or inducers of CYP3A (Carbamazepine, Dexamethasone, Glucocorticoids, Phenytoin Primidone, Progesterone, Phenobarbital, Sulfinpyrazone, Troglitazone)
9. Increased risk of bradycardia (eg, sick sinus syndrome or third degree atrioventricular block or documented preceding syncope probably due to bradycardia unless treated with pacemaker implantation).
10. Severe chronic obstructive pulmonary disease,
11. Peri-procedural administration IIb / IIIa inhibitors.
12. patient anable to attend the required follow-up or any other cause or condition makes the researcher to believe that the initiation of therapy under study would put the patient at increased risk
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: In the present study, in STEMI patients undergoing primary PCI we aim therefore to compare platelet inhibition achieved in patients loaded with ticagrelor followed by cangrelor (bolus plus infusion) vs ticagrelor alone loaded patients. We hypothesize a superior antiplatelet effect of a cangrelor strategy peri-interventionally and as early as within 15 min of cangrelor infusion. ;Secondary Objective: Not applicable;Primary end point(s): the primary end point of the study is the platelet reactivity between the two study groups in 15 minutes and will be measured in P2Y12 reaction units(PRU);Timepoint(s) of evaluation of this end point: 1 day
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary end point will be the Platelet reactivity between the two groups in 1, 2, and 4 hours, and the percentange of HPR in 15 minutes, 1, 2, 4 hours;Timepoint(s) of evaluation of this end point: 1 day