Clinical trial NCT04251039: in Patients With SCAD Undergoing Complex PCI, the RESPONSE Study"
Official title: "Efficacy and Safety of Oral/iv Therapy (Cangrelor) in Patients With SCAD Undergoing Complex PCI, the RESPONSE Study"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Disease
Lead sponsor: Fondazione GISE Onlus
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 550
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with SCAD undergoing complex PCI

Brief summary: Evaluation of Efficacy/Safety in Cangrelor use in patients with SCAD undergoing complex PCI.

Prospective, observational, multicenter registry.

Detailed description: SCAD patients routinely in the Italian centers undergo complex PCIs with pre-treatment with P2Y12 inhibitors or with P2Y12 inhibitors administration after procedure. This implies that participants receive interventions as part of routine medical care, and that researchers actually observe the effect of the intervention.

Eligibility criteria: Inclusion Criteria:

* Patient must be at least 65 years of age at the time of signing the Informed Consent Form
* Patient presenting with SCAD undergoing complex PCI and:

  * Type 2 Diabetes Mellitus;
  * CKD (Grade specified in CRF);
  * Complex SCAD: LMD, 3VD, bifurcation lesions, Rotablator, CTO, multiple Stents, total length of the stents must be greater than 60 mm.
* Patient is to be treated for de novo lesions located in previously untreated vessels.
* Patient must agree to undergo all required follow-up visits and data collection.

Exclusion Criteria:

* History of CABG;
* In stent restenosis;
* Patient with intolerance or contra-indications to treatment with aspirin, clopidogrel, prasugrel, ticagrelor, cangrelor, heparin, contrast media;
* Patient on chronic treatment with oral anticoagulants;
* Patient with neoplastic or rheumatic diseases;
* Use of dipyridamole, cilostazol, or anticoagulant therapy during the study period;
* Bleeding disorder
* History of an ischemic stroke or intracranial bleeding
* Intracranial vascular abnormality;
* Gastrointestinal bleeding within the previous 6 months or major surgery within the previous 30 days.
* Women who are pregnant/breastfeeding or who have the potential to become pregnant during the study;
* Patient with bleeding diathesis in whom antiplatelet drug is contraindicated;
* Concomitant indication to open heart surgery
* Inability to provide written informed consent
* Enrolment in another study within 1 month

Primary outcomes:
measure: Safety endpoint: Major bleedings according with Thrombolysis in Myocardial Infarction (TIMI) classification.
timeFrame: hour 48
Secondary outcomes:
measure: Efficacy endpoint: Long-term major adverse cardiac and cerebrovascular events MACCE (eg Death from any cause, Any Myocardial infarction, Revascularization, Stroke)
timeFrame: hour 48 and day 30
measure: Assessment of platelet reactivity
timeFrame: Day 0
measure: Number of Participants with stent thrombosis
timeFrame: hour 48
measure: Rehospitalisation due to unstable or progressive angina according to the Braunwald Unstable Angina Classification and the Canadian Cardiovascular Society Angina Classification.
timeFrame: Day 30
measure: Time to Coronary Artery Bypass Graft (CABG)
timeFrame: Day 30
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Ospedale Santa Maria
state: Puglia
Study officials:
affiliation: Ospedale Santa Maria (BA)
name: Alfredo Marchese, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: