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A Trial in Stable Intermediate Coronary Lesions and Grey-zone FFR Values

NCT02425969 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2017-03-03

No results posted yet for this study

Summary

In this randomised controlled trial of patients with stable angina and documented intermediate coronary disease with indeterminate or "grey-zone" Fractional Flow Reserve (FFR) we will randomise patients to either optimal medical therapy alone versus optimal medical therapy with PCI and they will be followed up for the primary endpoint of anginal control as measured by the Seattle Angina Questionnaire at 3 months.

Conditions

  • Grey-zone Fractional Flow Reserve
  • Intermediate Coronary Lesions
  • Stable Angina
  • Coronary Physiology

Interventions

PROCEDURE

PCI

Patients will have balloon angioplasty and coronary stent insertion for their grey-zone FFR lesion.

DRUG

Optimal Medical Therapy

Optimal Medical therapy consists of secondary prevention which will include high dose statin and aspirin as well as anti-anginal therapy according to ESC 2013 international treatment guidelines for stable angina as follows; B-Blocker or Calcium channel blocker as first line agents and Nicorandil or Nitrates or Ranolazine as second line treatment titrated against symptoms to maximum tolerated dose. ACE inhibitors or Angiotensin Receptor Blockers will be prescribed if patients also have a diagnosis of hypertension, LVEF ≤40%, diabetes or CKD where appropriate.

Sponsors & Collaborators

  • British Heart Foundation

    collaborator OTHER

  • University of Glasgow

    collaborator OTHER

  • Golden Jubilee National Hospital

    lead OTHER_GOV

Principal Investigators

  • Keith G Oldroyd, M.D. · National Health Service

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-10-01
Completion
2016-10-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02425969 on ClinicalTrials.gov