Parenteral Antiplatelet Agents in Real-world Spanish PCI Patients

Study Overview
=================
Brief Summary
-----------------
This registry will provide exploratory and descriptive information regarding contemporary practice patterns of parenteral antiplatelet therapy in the PCI (Percutaneous Coronary Intervention) setting and will investigate as well the short-term effectiveness and safety of the currently available parenteral antiplatelet agents in a cohort of real-world patients undergoing PCI in Spain.

Detailed Description
-----------------
The present study is an observational, multicenter, nationwide, prospective investigation in patients undergoing PCI due to any coronary syndrome (acute or chronic) and receiving parenteral antiplatelet agents, GPIs or cangrelor, as per clinical practice during the procedure. This investigation will provide exploratory and descriptive information regarding contemporary practice patterns of parenteral antiplatelet therapy in the PCI setting and will evaluate the short-term effectiveness and safety of the currently available parenteral antiplatelet agents in a cohort of patients undergoing PCI in Spain. Approximately 15 high-volume PCI-capable Spanish centers will participate in the present investigation with the intention to enroll circa 1.000 patients. The study is purely observational and no intervention will be performed in the included subjects because due to their participation in this investigation. Patients fulfilling inclusion and exclusion criteria will be included after providing written informed consent to participate in the current investigation. Patient characteristics, procedural details and pharmacological therapies will be collected after inclusion and clinical events will be registered at two time points: 48 hours and 30 days.

Official Title
-----------------
Practice Patterns of Antithrombotic Therapy in REAL-world Patients Undergoing PCI in Spain: Parenteral Antiplatelet Agents

Conditions
-----------------
Ischemic Heart Disease, Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Other: Parenteral antiplatelet agents


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Undergoing a PCI Use of a parenteral antiplatelet agent (GPIs or cangrelor)during the invasive procedure (PCI) Exclusion Criteria: Blood dyscrasia, bleeding diathesis or active bleeding at the time of the index procedure. Chronic oral anticoagulation. Recent history of stroke, TIA (Transient Ischemic Attack)or intracranial bleeding (<3 months prior to inclusion). Severe anemia (Hb<9g/dl) or platelet count <100x106/ml at the time of the index procedure. Any active neoplasm.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing PCI<br> | Other: Parenteral antiplatelet agents<br>* Patients undergoing PCI and receiving parenteral antiplatelet agents, cangrelor or glycoprotein IIb/IIIa inhibitors (GPIs), during the procedure as per clinical practice<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Net Adverse Clinical Events (NACE) | NACE defined as a the composite of all-cause death, recurrent myocardial infarction, stroke, target vessel revascularization, definite or probable stent thrombosis and BARC bleeding (type 2,3 and 5) will be evaluated at 48 hours from index procedure | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | All-cause of death will be evaluated at 48 hours from index procedure | 48 hours | 
| Myocardial infarction | Recurrent myocardial infarction will be evaluated at 48 hours from index procedure | 48 hours | 
| Stroke | Stroke will be evaluated at 48 hours from index procedure | 48 hours | 
| Target Vessel Revascularization | Target Vessel will be evaluated at 48 hours from index procedure | 48 hours | 
| Definite or probable stent thrombosis | Definite or probable stent thrombosis will be evaluated at 48 hours from index procedure | 48 hours | 
| BARC bleeding | BARC bleeding (type 2,3 and 5) will be evaluated at 48 hours from index procedure | 48 hours | 
| Rate of Net Adverse Clinical Events (NACE) | NACE defined as a the composite of all-cause death, recurrent myocardial infarction, stroke, target vessel revascularization, definite or probable stent thrombosis and BARC bleeding (type 2,3 and 5) will be evaluated at 30 days from index procedure | 30 days | 
| Death | All-cause of death will be evaluated at 30 days from index procedure | 30 days | 
| Myocardial infarction | Recurrent myocardial infarction will be evaluated at 30 days from index procedure | 30 days | 
| Stroke | Stroke will be evaluated at 30 days from index procedure | 30 days | 
| Target Vessel Revascularization | Target Vessel Revascularization will be evaluated at 30 days from index procedure | 30 days | 
| Definite or probable stent thrombosis | Definite or probable stent thrombosis will be evaluated at 30 days from index procedure | 30 days | 
| BARC bleeding | BARC bleeding will be evaluated at 30 days from index procedure | 30 days | 
| Cardiac death | Cardiac death will be evaluated at 48 hours from index procedure | 48 hours | 
| Cardiac death | Cardiac death will be evaluated at 30 days from index procedure | 30 days | 
| Transition to oral P2Y12 inhibitors | Proportion of patients transitioned to each oral P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) after the use of each parenteral antiplatelet agent (GPIs or cangrelor) will be evaluated at 24 hours from index procedure | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cangrelor, Percutaneous Coronary Intervention, Antiplatelet Drugs, Glycoprotein IIb/IIIa inhibitors