in Patients With SCAD Undergoing Complex PCI, the RESPONSE Study" (NCT04251039) | Clinical Trial Compass
UnknownNot Applicable
in Patients With SCAD Undergoing Complex PCI, the RESPONSE Study"
Italy550 participantsStarted 2022-12
Plain-language summary
Evaluation of Efficacy/Safety in Cangrelor use in patients with SCAD undergoing complex PCI.
Prospective, observational, multicenter registry.
Who can participate
Age range65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Safety endpoint: Major bleedings according with Thrombolysis in Myocardial Infarction (TIMI) classification.