STEEL Percutaneous Coronary Intervention

NCT02327624 | Completed Phase 4

• 1 other identifier: STH18423
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The principal hypothesis of this study is that two different maintenance regimens of ticagrelor are safe, tolerable and associated with significant inhibition of erythrocyte adenosine reuptake compared to clopidogrel in patients undergoing elective Percutaneous Coronary Intervention (PCI) for stable Coronary artery disease (CAD).

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Platelet function in the three treatment groups

  2 years

Secondary Outcomes (2)

• Rates of myocardial infarction following PCI

  2 years

• Plasma adenosine concentration in the three treatment groups

  2 years

Study Arms (3)

Clopidogrel

ACTIVE COMPARATOR

The standard antiplatelet treatment for patients is pretreatment with aspirin and clopidogrel. In this trial patients will be randomised in clopidogrel orTicagrelor of two doses

Drug: Clopidogrel

Ticagrelor 60

EXPERIMENTAL

Ticagrelor 60 is a new dosage to be tried in this trial.

Drug: Ticagrelor 60

Ticagrelor 90

EXPERIMENTAL

Ticagrelor 90 is used following clopidogrel as maintenance therapy with aspirin 75 mg daily and clopidogrel 75 mg daily following PCI for at least 1 month.

Drug: Ticagrelor 90

Interventions

Clopidogrel DRUG

Compare Clopidogrel to two doses of Ticagrelor 60 and 90

Clopidogrel

Ticagrelor 60 DRUG

Compare Clopidogrel to two doses of Ticagrelor 60 and 90

Ticagrelor 60

Ticagrelor 90 DRUG

Compare Clopidogrel to two doses of Ticagrelor 60 and 90

Ticagrelor 90

Eligibility Criteria

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

You may qualify if:

• Provision of informed consent prior to any study specific procedures
• Male or female aged greater than 18 years
• Previous invasive coronary angiography with plan for PCI with coronary stent implantation for stable coronary artery disease

You may not qualify if:

• Requirement for a chronic total occlusion to be crossed in order for any stent implantation to proceed
• Plan for coronary angiography with a view to PCI if appropriate (i.e. current coronary anatomy not known)
• Intention to use platelet function tests or genotyping to guide antiplatelet therapy
• Known allergy to or intolerance of aspirin, clopidogrel or ticagrelor
• Treatment with antiplatelet medication apart from aspirin or clopidogrel that cannot be stopped 10 days prior to PCI (e.g. ticagrelor, prasugrel, dipyridamole, ticlopidine, abciximab, tirofiban), for example because of continuing indication
• Planned treatment or consideration of treatment with oral antiplatelet medication other than aspirin or clopidogrel following PCI
• Planned use of a glycoprotein IIb/IIIa antagonist for the PCI procedure
• Myocardial infarction within the past 12 months
• Current or planned use of an oral anticoagulant (e.g. warfarin, dabigatran, rivaroxaban, apixaban)
• Previous history of intracranial haemorrhage or other intracranial pathology associated with increased bleeding risk
• Haemoglobin \< 100 g/L or other evidence of active bleeding
• Peptic ulceration documented by endoscopy within the last 3 months unless healing proven by repeat endoscopy
• History of acute or chronic liver disease (e.g. cirrhosis)
• Treatment in the last 10 days or requirement for ongoing treatment with a strong CYP3A4 inhibitor or inducer (see section 5.6.8)
• Requirement for ongoing treatment with simvastatin or lovastatin at a dose greater than 40 mg per day

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• AstraZeneca: collaborator

Study Sites (1)

Sheffield Teaching Hospitals NHS FT

Sheffield, United Kingdom

Location

Related Publications (1)

• Orme RC, Parker WAE, Thomas MR, Judge HM, Baster K, Sumaya W, Morgan KP, McMellon HC, Richardson JD, Grech ED, Wheeldon NM, Hall IR, Iqbal J, Barmby D, Gunn JP, Storey RF. Study of Two Dose Regimens of Ticagrelor Compared With Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention for Stable Coronary Artery Disease. Circulation. 2018 Sep 25;138(13):1290-1300. doi: 10.1161/CIRCULATIONAHA.118.034790. Epub 2018 Jul 24.

  PMID: 29930021 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 30, 2014
• Study Start: June 1, 2015
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: January 23, 2019

Record last verified: 2019-01

Locations

GB (1)