# US 2019/0167796 A1 · Methods of treating or preventing stent thrombosis

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- Number: US 2019/0167796 A1
- Document ID: US20190167796A1
- Status: Published application
- Kind: A1
- Application number: 15/892,070
- Filed: 2018-02-08
- Published: 2019-06-06
- Earliest claimed: 2009-11-11
- Assignees: Chiesi Farmaceutici S.p.A.
- Applicants: Chiesi Farmaceutici S.p.A
- Inventors: Clive Arthur Arculus-Meanwell; Simona Skerjanec
- Web page: https://patentgrep.com/patent/US20190167796A1

## CPC

- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/19: lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)}
- A61K 31/7076: containing purines, e.g. adenosine, adenylic acid
- A61K 38/10: Peptides having 12 to 20 amino acids {(A61K38/043 - A61K38/046 take precedence)}
- A61K 38/58: from leeches, e.g. hirudin, eglin
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/02: Inorganic compounds
- A61P 7/02: Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 41/00: Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention is directed to the following: methods of treating or preventing stent thrombosis using pharmaceutical compositions comprising cangrelor and optionally bivalirudin; methods of reducing mortality in a subject undergoing stent implantation using pharmaceutical compositions comprising cangrelor and optionally bivalirudin; medicaments comprising cangrelor and optionally bivalirudin useful for treating or preventing stent thrombosis, or useful for reducing mortality in a subject undergoing stent implantation; pharmaceutical compositions comprising cangrelor and bivalirudin; and methods of preparing a medicament comprising cangrelor and optionally bivalirudin useful for treating or preventing stent thrombosis, or useful for reducing mortality in a subject undergoing stent implantation.

## Claims

### Claim 1

A method of treating or preventing stent thrombosis in a subject in need thereof, comprising administering to the subject an effective amount of a pharmaceutical composition comprising cangrelor, thereby treating or preventing stent thrombosis in a subject.

### Claim 2 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition further comprises bivalirudin.

### Claim 3

A method of reducing mortality in a subject undergoing stent implantation, comprising administering to the subject an effective amount of a pharmaceutical composition comprising cangrelor, thereby reducing mortality in a subject undergoing stent implantation.

### Claim 4 (depends on 3)

The method of claim 3, wherein the pharmaceutical composition further comprises bivalirudin.

### Claim 5

A method of treating or preventing myocardial infarction in a subject in need thereof, comprising administering to the subject an effective amount of a pharmaceutical composition comprising cangrelor, thereby treating or preventing myocardial infarction in a subject.

### Claim 6 (depends on 5)

The method of claim 5, wherein the pharmaceutical composition further comprises bivalirudin.

### Claim 7 (depends on 1)

The method of claim 1, wherein stent thrombosis is induced by implantation of a bare-metal stent or a drug-eluting stent into the subject.

### Claim 8 (depends on 1)

The method of claim 1, wherein stent thrombosis is intraprocedural stent thrombosis, acute stent thrombosis, sub-acute stent thrombosis, late stent thrombosis or very late stent thrombosis.

### Claim 9 (depends on 1)

The method of claim 1, wherein preventing stent thrombosis is prevention during percutaneous coronary intervention (PCI) or other vascular stent implantation.

### Claim 10 (depends on 3)

The method of claim 3, wherein stent implantation is implantation of a bare-metal stent or a drug-eluting stent into the subject.

### Claim 11 (depends on 3)

The method of claim 3, wherein stent implantation is during percutaneous coronary intervention (PCI) or other vascular stent implantation.

### Claim 12 (depends on 5)

The method of claim 5, wherein myocardial infarction is induced by implantation of a bare-metal stent or a drug-eluting stent into the subject.

### Claim 13 (depends on 5)

The method of claim 5, wherein myocardial infarction is caused by intraprocedural stent thrombosis, acute stent thrombosis, sub-acute stent thrombosis, late stent thrombosis, very late stent thrombosis, or occlusion of a coronary artery.

### Claim 14 (depends on 5)

The method of claim 5, wherein myocardial infarction is experienced during percutaneous coronary intervention (PCI) or other vascular stent implantation.

### Claim 15 (depends on 1)

The method of claim 1, wherein the subject is undergoing vascular stent implantation.

### Claim 16 (depends on 1)

The method of claim 1, wherein the subject has undergone vascular stent implantation.

### Claim 17 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition is administered to the subject orally, as an intravenous bolus, as a continuous intravenous infusion, or as an intravenous bolus followed by a continuous intravenous infusion.

### Claim 18 (depends on 17)

The method of claim 17, wherein the pharmaceutical composition is administered to the subject in as a continuous intravenous infusion over a period of at least about two hours.

### Claim 19 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition is administered to the subject orally, as an intravenous bolus, as a continuous intravenous infusion, or as an intravenous bolus followed by a continuous intravenous infusion within about 1 hour prior to beginning stent implantation.

### Claim 20 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition is administered to the subject orally, as an intravenous bolus, as a continuous intravenous infusion, or as an intravenous bolus followed by a continuous intravenous infusion during stent implantation.

### Claim 21 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition is administered to the subject orally, as an intravenous bolus, as a continuous intravenous infusion, or as an intravenous bolus followed by a continuous intravenous infusion after completion of stent implantation.

### Claim 22 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition is administered to the subject orally, as an intravenous bolus, as a continuous intravenous infusion, or as an intravenous bolus followed by a continuous intravenous infusion about 1 hour prior to stent implantation; and administered to the subject orally, as an intravenous bolus, as a continuous intravenous infusion, or as an intravenous bolus followed by a continuous intravenous infusion during the period of stent implantation.

### Claim 23 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition is administered to the subject orally, as an intravenous bolus, as a continuous intravenous infusion, or as an intravenous bolus followed by a continuous intravenous infusion about 1 hour prior to stent implantation; administered to the subject orally, as an intravenous bolus, as a continuous intravenous infusion, or as an intravenous bolus followed by a continuous intravenous infusion during the period of stent implantation; and administered to the subject orally, as an intravenous bolus, as a continuous intravenous infusion, or as an intravenous bolus followed by a continuous intravenous infusion for a period of about 2 hours upon completion of implantation.

### Claim 24 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition is administered to the subject orally, as an intravenous bolus, as a continuous intravenous infusion, or as an intravenous bolus followed by a continuous intravenous infusion during the period of stent implantation; and administered to the subject orally, as an intravenous bolus, as a continuous intravenous infusion, or as an intravenous bolus followed by a continuous intravenous infusion for a period of about 2 hours upon completion of implantation.

### Claim 25 (depends on 3)

The method of claim 3, wherein mortality is reduced over a period of about one year after stent implantation.

### Claim 26 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition comprises about 1 mg/mL cangrelor.

### Claim 27 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition comprises about 5 mg/mL cangrelor.

### Claim 28 (depends on 2)

The method of claim 2, wherein the pharmaceutical composition comprises about 1 mg/mL cangrelor and about 1 mg/mL bivalirudin.

### Claim 29 (depends on 2)

The method of claim 2, wherein the pharmaceutical composition comprises about 1 mg/mL cangrelor and about 5 mg/mL bivalirudin.

### Claim 30 (depends on 2)

The method of claim 2, wherein the pharmaceutical composition comprises about 5 mg/mL cangrelor and about 1 mg/mL bivalirudin.

### Claim 31 (depends on 2)

The method of claim 2, wherein the pharmaceutical composition comprises about 5 mg/mL cangrelor and about 5 mg/mL bivalirudin.

### Claim 32 (depends on 1)

The method of claim 1, wherein the patient has suffered a stroke.

### Claim 33 (depends on 3)

The method of claim 3, wherein the patient has suffered a stroke.

### Claim 34 (depends on 5)

The method of claim 5, wherein the patient has suffered a stroke.