NCT03917914CompletedPhase 3
Preventing Adverse Cardiac Events in COPD
Preventing Adverse Cardiac Events in Chronic Obstructive Pulmonary Disease
Source: ClinicalTrials.gov · Last updated 16 May 2025
Brief summary (registry, in English)
A double-blind, randomised controlled trial in participants with COPD to assess the efficacy of proactive treatment of cardiac risk in people with COPD. We hypothesise that treating known and undiagnosed CVD in COPD participants will improve both cardiac and respiratory outcomes.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 280 (actual)
- First submitted
- 10 Apr 2019
- Start date
- 30 Jun 2020
- Primary completion date
- 31 Mar 2025
- Lead sponsor
- The George Institute
- Diseases
- COPD
- NCT number
- NCT03917914
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 280
- From 30 Jun 2020 to the primary completion date, 31 Mar 2025
- 24 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent therapy with any other β-blocker
- Currently using or have been prescribed LTOT or resting saturated oxygen level \<90% when stable
- Clinical instability since a MACE in the previous 12 weeks
Other illness
- Clinically significant pulmonary hypertension, which in the investigator's opinion would be a contraindication for β-blocker therapy
- Severe end-stage peripheral vascular disease
- 2nd or 3rd degree heart block
- Expected survival is less than 12 months, or in the investigator's opinion, the person has such unstable disease (of any type) that maintaining 12 months' participation would be unlikely
- Lower respiratory tract infection or AECOPD within the last 8 weeks
- Coexistent illness which precludes participation in the study (poorly controlled diabetes, active malignancy)
Lab values
- Severe end-stage liver disease defined by INR\>1.3 and albumin\<30g/L or portal hypertension/ascites
Age
- Females of child-bearing age and capability who are pregnant or breastfeeding or those in this group not using adequate birth control
Other
- Participants will be ineligible for the study if they have any of the following:
- Resting HR \<60bpm
- Unstable left HF (i.e. symptomatic and/or necessary change in management in the last 12 weeks, or in clinicians' opinion)
- COPD not clinically stable as determined by the investigator
- In the clinician's view, have asthma-COPD overlap or co-existent asthma are present; or an improvement in FEV1 ≥400mL post-bronchodilator is observed on two occasions
- High chance in the view of the treating physician that the potential participant will not adhere to study requirements
Who the study is looking for
- Participants will be eligible for this study if they qualify on all of the following:
- Have provided written informed consent
- Have COPD defined by the 2019 Global Initiative for Chronic Obstructive Lung Disease (GOLD) diagnostic criteria
- Aged 40-85 years
- FEV1 ≥30% and ≤70% predicted post-bronchodilator
- FEV1/FVC \<0.7 post-bronchodilator
- Have had a COPD exacerbation in the previous 24 months requiring oral corticosteroid, antibiotics, or both
- If taking maintenance OCS, dosage is stable and ≤10mg daily for 4 weeks prior to randomisation
- Resting SBP ≥100mmHg
- SBP and spirometry criteria must be met after the test dose of bisoprolol of 1.25mg
- (New Zealand only) A history of cardiovascular disease, including heart failure, ischaemic heart disease, tachyarrhythmias, and hypertension
Age in the registry: 40 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
| Prince Charles Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
| Campbelltown Hospital Coordinator of this site? Confirm its status | Campbelltown | Australia | Unknown status |
| Liverpool Hospital Coordinator of this site? Confirm its status | Liverpool | Australia | Unknown status |
| Fiona Stanley Hospital Coordinator of this site? Confirm its status | Murdoch | Australia | Unknown status |
| John Hunter Hospital & Hunter Medical Research Institute Coordinator of this site? Confirm its status | Newcastle | Australia | Unknown status |
| TrialsWest Pty Ltd Coordinator of this site? Confirm its status | Perth | Australia | Unknown status |
| Institute for Respiratory Health Coordinator of this site? Confirm its status | Perth | Australia | Unknown status |
| Gold Coast University Hospital Coordinator of this site? Confirm its status | Southport | Australia | Unknown status |
| Concord Repatriation General Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Westmead Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| St. John's Medical College Hospital Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| Postgraduate Institute of Medical Education and Research Coordinator of this site? Confirm its status | Chandigarh | India | Unknown status |
| All India Institute of Medical Sciences Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Coordinator of this site? Confirm its status | Rohtak | India | Unknown status |
| Central Chest Clinic - Borella Coordinator of this site? Confirm its status | Colombo | Sri Lanka | Unknown status |
| Central Chest Clinic Coordinator of this site? Confirm its status | Colombo | Sri Lanka | Unknown status |
| Kandy National Hospital Coordinator of this site? Confirm its status | Kandy | Sri Lanka | Unknown status |
| National Institute of Respiratory Diseases Coordinator of this site? Confirm its status | Welisara | Sri Lanka | Unknown status |
| Middlemore Hospital Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| University of Otago Coordinator of this site? Confirm its status | Christchurch | New Zealand | Unknown status |
| Dunedin Hospital Coordinator of this site? Confirm its status | Dunedin | New Zealand | Unknown status |
| Waikato Hospital Coordinator of this site? Confirm its status | Hamilton | New Zealand | Unknown status |
| Medical Research Institute of New Zealand Coordinator of this site? Confirm its status | Wellington | New Zealand | Unknown status |
Related publications
- Bisoprolol to prevent adverse cardiac events (PACE) in COPD: a multicentre, double-blind, randomised, controlled, phase 3 trial.Lancet Respir Med · 2026 · PMID 41579873
This page is information, not medical advice. Discuss any trial with your doctor.