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Stable Angina PectorisPhase 2LOBSTRNCT00825604

Quality of Life and Target Achievement After Treatment of Patients With Stable Angina Pectoris

A Phase 2 study testing Percutaneous coronary angioplasty (PCI) in people with Stable Angina Pectoris, run by Göteborg University at 1 site in Sweden.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to, in patients with stable angina pectoris, assess the additional benefit of PCI on top of optimized medical treatment, physical training and smoking cessation with regard to quality of life, achievement of target of treatment and clinical events such as death, acute myocardial… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stable Angina Pectoris
What is being tested?
Percutaneous coronary angioplasty (PCI)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteSweden
Study dates
Jan 2009to Jan 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Stable coronary artery disease
  • Angina pectoris with at least angina class 2 according to Canadian Cardiovascular Society (CCS)
  • Angiographic verified stenos in a native vessel
  • Accepted for PCI

Who cannot join

  • Instable coronary artery disease or AMI withín two months
  • CCS class IV
  • Stenosis in Left main and/or proximal LAD
  • NYHA- III-IV
  • Fall in blood pressure during exercise test > 10mm Hg, measured two times
  • Contraindication or allergy against clopidogrel or ASA
Show all 9Show fewer
  • Unable to communicate verbal or i writing
  • Unwillingness to participate in the study
  • Participating in an other study

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Sahlgrenska University hospital

    Gothenburg, 41345

Other trials in Sweden

About this study

Official title: Quality of Life and Achievement of Target of Treatment After Optimized Medical Treatment, Physical Training and Smoking Cessation With or Without Percutaneous Coronary Intervention in Patients With Stable Angina Pectoris.

The purpose of this study is to, in patients with stable angina pectoris, assess the additional benefit of PCI on top of optimized medical treatment, physical training and smoking cessation with regard to quality of life, achievement of target of treatment and clinical events such as death, acute myocardial infarction, stroke and revascularization.

Read the detailed description

Patients with stable angina pectoris with a significant coronary stenosis will be randomized to optimized medical treatment, physical training and smoking cessation or to optimized medical treatment, physical training, smoking cessation and complimentary treatment with PCI. All patients will be followed up at six months and at one and five years regarding symptoms, blood lipids, systemic blood pressure, physical training status, smoking habits, and maximal exercise ECG.

Achievement of target of treatment will be measured by questions regarding the patients' expectation of the treatment at baseline and at a 6 month follow-up. The questions at 6 months will be based on the interviews at inclusion. Furthermore quality of life will be measured with three different measuring instrument; SF-36 short form, Seattle Angina Questionnaire (SAQ), and EQ-5D. These instruments will be given to the patients at baseline, at six months and at the five year follow up.

Being tested
Percutaneous coronary angioplasty (PCI)
Keywords
stable coronary artery disease, quality of life, target achievement, physical training, percutaneous coronary intervention
Medical subject headings
Angina, Stable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous coronary angioplasty (PCI)Procedure or surgery

    Also called PCI

    optimized medical treatment, physical training and smoking cessation with complimentary treatment with coronary angioplasty (PCI):

Study groups in NCT00825604
Study groupRoleWhat they receive
Without PCINo interventionOptimized medical treatment, physical training and smoking cessation
With PCIActive comparatoroptimized medical treatment, physical training and smoking cessation with complimentary treatment with percutaneous coronary intervention(PCI)
Receives: Procedure: Percutaneous coronary angioplasty (PCI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of life measured by SF36

    Measured: 6 months

Secondary outcomes (5)

  1. Achievement of target of treatment based on interview of the patients

    Measured: 6 months

  2. Death, myocardial infarction, stroke or new revascularization

    Measured: 6 months, one year and five years after randomization

  3. To assess expectations of treatment at inclusion and fulfilment of expectations

    Measured: 6 months

  4. Quality of life measured by EQ5D and Seattle angina questionaire

    Measured: 6 months and 5 years

  5. Health economy

    Measured: 6 months, one year and five years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionJan 2010
  4. Study completionJan 2010

Why it stopped: Because of poor inclusion difficulties to find patient

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00825604
Sponsor's protocol ID
Dnr: 056-08
Acronym
LOBSTR
Status last verified
May 2019
First submitted
20 Jan 2009
Last updated
21 May 2019
Results posted
No
Data monitoring committee
No

Publications

  • Boden WE, O'Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, Knudtson M, Dada M, Casperson P, Harris CL, Chaitman BR, Shaw L, Gosselin G, Nawaz S, Title LM, Gau G, Blaustein AS, Booth DC, Bates ER, Spertus JA, Berman DS, Mancini GB, Weintraub WS; COURAGE Trial Research Group. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007 Apr 12;356(15):1503-16. doi: 10.1056/NEJMoa070829. Epub 2007 Mar 26.

    PubMed 17387127

  • Henderson RA, Pocock SJ, Clayton TC, Knight R, Fox KA, Julian DG, Chamberlain DA; Second Randomized Intervention Treatment of Angina (RITA-2) Trial Participants. Seven-year outcome in the RITA-2 trial: coronary angioplasty versus medical therapy. J Am Coll Cardiol. 2003 Oct 1;42(7):1161-70. doi: 10.1016/s0735-1097(03)00951-3.

    PubMed 14522473

  • Pitt B, Waters D, Brown WV, van Boven AJ, Schwartz L, Title LM, Eisenberg D, Shurzinske L, McCormick LS. Aggressive lipid-lowering therapy compared with angioplasty in stable coronary artery disease. Atorvastatin versus Revascularization Treatment Investigators. N Engl J Med. 1999 Jul 8;341(2):70-6. doi: 10.1056/NEJM199907083410202.

    PubMed 10395630

  • Weintraub WS, Spertus JA, Kolm P, Maron DJ, Zhang Z, Jurkovitz C, Zhang W, Hartigan PM, Lewis C, Veledar E, Bowen J, Dunbar SB, Deaton C, Kaufman S, O'Rourke RA, Goeree R, Barnett PG, Teo KK, Boden WE; COURAGE Trial Research Group; Mancini GB. Effect of PCI on quality of life in patients with stable coronary disease. N Engl J Med. 2008 Aug 14;359(7):677-87. doi: 10.1056/NEJMoa072771.

    PubMed 18703470

  • Sullivan M, Karlsson J. The Swedish SF-36 Health Survey III. Evaluation of criterion-based validity: results from normative population. J Clin Epidemiol. 1998 Nov;51(11):1105-13. doi: 10.1016/s0895-4356(98)00102-4.

    PubMed 9817128

  • Spertus JA, Winder JA, Dewhurst TA, Deyo RA, Fihn SD. Monitoring the quality of life in patients with coronary artery disease. Am J Cardiol. 1994 Dec 15;74(12):1240-4. doi: 10.1016/0002-9149(94)90555-x.

    PubMed 7977097

  • Spertus JA, Winder JA, Dewhurst TA, Deyo RA, Prodzinski J, McDonell M, Fihn SD. Development and evaluation of the Seattle Angina Questionnaire: a new functional status measure for coronary artery disease. J Am Coll Cardiol. 1995 Feb;25(2):333-41. doi: 10.1016/0735-1097(94)00397-9.

    PubMed 7829785

  • Sullivan M, Karlsson J, Ware JE Jr. The Swedish SF-36 Health Survey--I. Evaluation of data quality, scaling assumptions, reliability and construct validity across general populations in Sweden. Soc Sci Med. 1995 Nov;41(10):1349-58. doi: 10.1016/0277-9536(95)00125-q.

    PubMed 8560302

  • Jones B, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence: the importance of rigorous methods. BMJ. 1996 Jul 6;313(7048):36-9. doi: 10.1136/bmj.313.7048.36.

    PubMed 8664772

  • Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.

    PubMed 11491192

  • Hambrecht R, Walther C, Mobius-Winkler S, Gielen S, Linke A, Conradi K, Erbs S, Kluge R, Kendziorra K, Sabri O, Sick P, Schuler G. Percutaneous coronary angioplasty compared with exercise training in patients with stable coronary artery disease: a randomized trial. Circulation. 2004 Mar 23;109(11):1371-8. doi: 10.1161/01.CIR.0000121360.31954.1F. Epub 2004 Mar 8.

    PubMed 15007010

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Percutaneous coronary angioplasty (PCI) in people with Stable Angina Pectoris, run by Göteborg University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life measured by SF36 (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00825604, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.

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