Effects of Ticagrelor Versus Prasugrel on Coronary Microcirculation in Patients Undergoing Elective Percutaneous Coronary Intervention: Results of the PROtecting MICROcirculation During Coronary Angioplasty (PROMICRO)-3 Randomised Study

NCT05643586 | Completed Phase 4 DMC

• 1 other identifier: 2017/010
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Besides being at least as effective as prasugrel in inhibiting platelet aggregation, ticagrelor has been shown to have additional properties potentially affecting coronary microcirculation. We sought to compare the effects of ticagrelor and prasugrel on absolute coronary blood flow (Q) and microvascular resistance (R) in patients with stable coronary artery disease (CAD) undergoing elective percutaneous coronary intervention (PCI). The PROMICRO-3 study shows that in patients with stable CAD undergoing PCI pre-treatment with a loading dose of ticagrelor compared with prasugrel improves post-procedural coronary flow and microvascular function and seems to reduce the related myocardial injury.

Conditions

Coronary Artery Disease

Keywords

Coronary Flow; Coronary Resistances; Platelet Reactivity

Outcome Measures

Primary Outcomes (2)

• Post PCI coronary flow

  Post PCI flow measured according to continous termodiluition

  Immediately after the procedure

• Post PCI coronary resistance

  Post PCI coronary resistance measured according to continous termodiluition

  Immediately after the procedure

Secondary Outcomes (1)

• Periprocedural myocardial injury

  8 and 24 hours following the procedure

Study Arms (2)

Prasugrel Group

EXPERIMENTAL

Patient treated with 60 mg prasugrel 12 hours before the procedure

Drug: Prasugrel

Ticagrelor

EXPERIMENTAL

Patient treated with 180 mg ticagrelor 12 hours before the procedure

Drug: Ticagrelor

Interventions

Ticagrelor DRUG

Patient treated with 180 mg ticagrelor 12 hours before the procedure

Also known as: Ticagrelor 180 mg

Ticagrelor

Prasugrel DRUG

Patient treated with 60 mg prasugrel 12 hours before the procedure

Also known as: Pasugrel 60 mg

Prasugrel Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Paitents with stable CAD referred to elective percutaneous coronary intervention (PCI) of an isolated, functionally significant (as confirmed by a fractional flow reserve \[FFR\] \<0.80) stenosis located in the proximal two-thirds of a major coronary artery

You may not qualify if:

• age \<18 years or ≥75 years, body weight \<60 kg, previous transient ischemic attack (TIA) or stroke, acute coronary syndromes, administration of glycoprotein IIb/IIIa inhibitors, platelet count \<70x109/l, high bleeding risk (active internal bleeding, history of haemorrhagic stroke, intracranial neoplasm, arteriovenous malformation or aneurysm, ischemic stroke in the previous 3 months), coronary bypass graft surgery in the previous 3 months, severe chronic renal failure (serum creatinine ≥2 mg/dl), previous myocardial infarction, left ventricular ejection fraction less than 50%, left ventricle wall-motion abnormalities, left ventricular hypertrophy, chronic total occlusion, lesions with extensive calcifications requiring rotational atherectomy, in-stent restenosis, bifurcation lesions with side branch diameter of more than 2 mm, ostial lesion, and contraindications to adenosine

Sponsors & Collaborators

• Germano Di Sciascio: lead
• Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium: collaborator
• Department of Advanced Biomedical Sciences, University of Naples Federico II, Italy: collaborator
• CardioRISC, C-TRIC, Derry/Londonderry, Northern Ireland, UK: collaborator
• University of Lausanne Hospitals: collaborator

Study Sites (1)

Aalst cardiovascular center

Aalst, 9300, Belgium

Location

Related Publications (8)

• Mangiacapra F, Peace AJ, Di Serafino L, Pyxaras SA, Bartunek J, Wyffels E, Heyndrickx GR, Wijns W, De Bruyne B, Barbato E. Intracoronary EnalaPrilat to Reduce MICROvascular Damage During Percutaneous Coronary Intervention (ProMicro) study. J Am Coll Cardiol. 2013 Feb 12;61(6):615-21. doi: 10.1016/j.jacc.2012.11.025. Epub 2013 Jan 2.

  PMID: 23290547 BACKGROUND

• Mangiacapra F, Di Gioia G, Pellicano M, Di Serafino L, Bressi E, Peace AJ, Bartunek J, Wijns W, De Bruyne B, Barbato E. Effects of Prasugrel Versus Clopidogrel on Coronary Microvascular Function in Patients Undergoing Elective PCI. J Am Coll Cardiol. 2016 Jul 12;68(2):235-7. doi: 10.1016/j.jacc.2016.04.039. No abstract available.

  PMID: 27386781 BACKGROUND

• Cattaneo M, Schulz R, Nylander S. Adenosine-mediated effects of ticagrelor: evidence and potential clinical relevance. J Am Coll Cardiol. 2014 Jun 17;63(23):2503-2509. doi: 10.1016/j.jacc.2014.03.031. Epub 2014 Apr 23.

  PMID: 24768873 BACKGROUND

• Jaffe R, Dick A, Strauss BH. Prevention and treatment of microvascular obstruction-related myocardial injury and coronary no-reflow following percutaneous coronary intervention: a systematic approach. JACC Cardiovasc Interv. 2010 Jul;3(7):695-704. doi: 10.1016/j.jcin.2010.05.004.

  PMID: 20650430 BACKGROUND

• Xaplanteris P, Fournier S, Keulards DCJ, Adjedj J, Ciccarelli G, Milkas A, Pellicano M, Van't Veer M, Barbato E, Pijls NHJ, De Bruyne B. Catheter-Based Measurements of Absolute Coronary Blood Flow and Microvascular Resistance: Feasibility, Safety, and Reproducibility in Humans. Circ Cardiovasc Interv. 2018 Mar;11(3):e006194. doi: 10.1161/CIRCINTERVENTIONS.117.006194.

  PMID: 29870386 BACKGROUND

• Gallinoro E, Candreva A, Colaiori I, Kodeboina M, Fournier S, Nelis O, Di Gioia G, Sonck J, van 't Veer M, Pijls NHJ, Collet C, De Bruyne B. Thermodilution-derived volumetric resting coronary blood flow measurement in humans. EuroIntervention. 2021 Oct 1;17(8):e672-e679. doi: 10.4244/EIJ-D-20-01092.

  PMID: 33528358 BACKGROUND

• Mangiacapra F, Barbato E, Patti G, Gatto L, Vizzi V, Ricottini E, D'Ambrosio A, Wijns W, Di Sciascio G. Point-of-care assessment of platelet reactivity after clopidogrel to predict myonecrosis in patients undergoing percutaneous coronary intervention. JACC Cardiovasc Interv. 2010 Mar;3(3):318-23. doi: 10.1016/j.jcin.2009.12.012.

  PMID: 20298992 BACKGROUND

• Mangiacapra F, Colaiori I, Di Gioia G, Pellicano M, Heyse A, Paolucci L, Peace A, Bartunek J, de Bruyne B, Barbato E. Effects of ticagrelor and prasugrel on coronary microcirculation in elective percutaneous coronary intervention. Heart. 2023 Dec 20;110(2):115-121. doi: 10.1136/heartjnl-2022-321868.

  PMID: 37316163 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Ticagrelor; Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization assignment for each patient was kept in a sealed envelope. At least 12 hours before PCI, a study nurse not involved in the procedure was responsible of opening the sealed envelope and administering study drugs according to treatment allocation. Both the patient and the catheterization laboratory team (operator and scrubbed nurse) were blinded to the assigned treatment. The PCI procedures were performed by standard technique.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Model Details: Patients were randomly assigned to receive loading doses of either ticagrelor (180 mg) or prasugrel (60 mg) at least 12 hours before intervention. Assignment to one of the two treatments was determined by a computer-based randomization system.

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 8, 2022
• Study Start: December 1, 2017
• Primary Completion: April 14, 2019
• Study Completion: April 14, 2019
• Last Updated: December 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

BE (1)