Angina PectorisPhase 2GOLD-PCINCT02127996
GLP-1 Loading During Elective Percutaneous Coronary Intervention
A Phase 2 study testing GLP-1 in people with Angina Pectoris and Myocardial Infarction, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Angina is caused by narrowings or blockages within coronary arteries. Coronary angioplasty and stenting is performed for people with angina to improve the blood supply to the heart by placing metal tubes within the artery using balloon inflation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina Pectoris, Myocardial Infarction, Reperfusion Injury
- What is being tested?
- GLP-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 193 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2015to Jul 2021
- 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
- Undergoing elective PCI
- Age over 18
- Able to give informed consent
Who cannot join
- Severe co-morbidity (expected life expectancy < 6 months)
- Nicorandil, glibenclamide, sitagliptin, vildagliptin, saxagliptin, linagliptin, liraglutide, exenatide and insulin use
- Women of child bearing age
- Breast-feeding women
- Myocardial infarction within the previous 3 months
- Baseline elevation of Troponin I before PCI
- Chronic Renal Impairment (serum creatinine > 160 μmol/l)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Papworth Hospital
Cambridge, Cambridgeshire, CB23 3RE
About this study
Official title: A Study to Investigate the Protective Effects of Glucagon-like Peptide-1 (GLP-1) in Patients Undergoing Elective Angioplasty and Stenting (GOLD-PCI)
Angina is caused by narrowings or blockages within coronary arteries. Coronary angioplasty and stenting is performed for people with angina to improve the blood supply to the heart by placing metal tubes within the artery using balloon inflation. The procedure risks small but significant damage to the heart muscle downstream of the balloon.
Glucagon like peptide 1 (GLP 1) is a naturally occurring hormone secreted by cells in the gut in response to food. It acts by stimulating the release of insulin. In the heart it acts to increase glucose uptake into cardiac muscle. GLP-1 can protect the heart and improve heart muscle performance in people with coronary artery disease in physiological studies. This study which assesses whether GLP-1 protects the heart during coronary angioplasty and stenting.
The hypothesis is that GLP-1 given during elective coronary angioplasty and stenting will reduce cardiac troponin rise (a measure of heart muscle damage) compared to placebo.
- Being tested
- GLP-1, placebo
- Keywords
- Angina Pectoris, Percutaneous Coronary Intervention, Myocardial Infarction, Glucagon-Like Peptide 1, Reperfusion Injury
- Medical subject headings
- Angina Pectoris, Myocardial Infarction, Reperfusion Injury, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1Drug
Also called GLP-1 (7-36) amide
GLP-1 (7-36) amide infused at 1.2 pmol/Kg/min
placeboDrug
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Placebo comparator | Infusion of Normal Saline during Percutaneous Coronary Intervention Receives: Drug: placebo |
| GLP-1 | Experimental | Infusion of GLP-1 (7-36) amide during elective percutaneous coronary intervention Receives: Drug: GLP-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Troponin I level
Incidence of Troponin I elevation of > 5 x 99th percentile upper reference limit on blood test at approximately 6 hours post procedure.
Measured: 6 Hours following angioplasty or stenting
Secondary outcomes (8)
Major Adverse Cardiovascular or Cerebrovascular Event (MACCE) Rates
MACCE rate (death, stent thrombosis, myocardial infarction, acute coronary syndrome, hospitalisation with heart failure, stroke)- these will be patient reported and confirmed by interrogation of hospital records and interrogation of local and national databases.
Measured: From date of randomisation until the date of first event assessed up to 6 months
Plasma Creatine Kinase - Myocardial Bound (CKMB) level
CKMB level on blood test at 6 hours following angioplasty or stenting
Measured: 6 hours
Myocardial Flow Grade after Angioplasty or Stenting
Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale
Measured: Measured during procedure
MACCE Rates
MACCE rate (death, stent thrombosis, myocardial infarction, acute coronary syndrome, hospitalisation with heart failure, stroke)- these will be patient reported and confirmed by interrogation of hospital records and interrogation of local and national databases.
Measured: From date of randomisation until the date of first event assessed up to 12 months
MACCE Rates
MACCE rate (death, stent thrombosis, myocardial infarction, acute coronary syndrome, hospitalisation with heart failure, stroke)- these will be patient reported and confirmed by interrogation of hospital records and interrogation of local and national databases.
Measured: From date of randomisation until the date of first event assessed up to 60 months
Ischaemic symptoms during balloon occlusion
Presence or absence or of symptoms of myocardial ischaemia during the procedure
Measured: Assessed during procedure
Myocardial Blush Grade following angioplasty or stenting
Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale
Measured: Measured during procedure
Electrocardiographic (ECG) Changes during procedure
Presence or absence of ECG changes reflective of myocardial ischaemia during the procedure
Measured: Assessed during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startMar 2015
- Primary completion31 Mar 2017
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Stephen Hoole, MA MD FRCP, Principal investigator, Papworth Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127996
- Sponsor's protocol ID
- P01799
- Acronym
- GOLD-PCI
- Status last verified
- Jun 2018
- First submitted
- 24 Apr 2014
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Giblett JP, Clarke S, Zhao T, McCormick LM, Braganza DM, Densem CG, O'Sullivan M, Adlam D, Clarke SC, Steele J, Fielding S, West NEJ, Villar SS, Hoole SP. The role of Glucagon-Like Peptide 1 Loading on periprocedural myocardial infarction During elective PCI (GOLD-PCI study): A randomized, placebo-controlled trial. Am Heart J. 2019 Sep;215:41-51. doi: 10.1016/j.ahj.2019.05.013. Epub 2019 Jun 9.
PubMed 31277053
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Protective Effects of Glucagon-like Peptide-1 (GLP-1) in Patients Undergoing Elective Angioplasty and Stenting (GOLD-PCI)
- ClinicalTrials.gov ID
- NCT02127996
- Acronym / sponsor ID
- GOLD-PCI / P01799
- Keywords
- Angina Pectoris, Percutaneous Coronary Intervention, Myocardial Infarction, Glucagon-Like Peptide 1, Reperfusion Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Study start
- Mar 2015
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- Jul 2021 (estimated)
- First posted
- 1 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Angina is caused by narrowings or blockages within coronary arteries. Coronary angioplasty and stenting is performed for people with angina to improve the blood supply to the heart by placing metal tubes within the artery using balloon inflation. The procedure risks small but significant damage to the heart muscle downstream of the balloon.
Glucagon like peptide 1 (GLP 1) is a naturally occurring hormone secreted by cells in the gut in response to food. It acts by stimulating the release of insulin. In the heart it acts to increase glucose uptake into cardiac muscle. GLP-1 can protect the heart and improve heart muscle performance in people with coronary artery disease in physiological studies. This study which assesses whether GLP-1 protects the heart during coronary angioplasty and stenting.
The hypothesis is that GLP-1 given during elective coronary angioplasty and stenting will reduce cardiac troponin rise (a measure of heart muscle damage) compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Placebo comparator | Drug: placeboInfusion of Normal Saline during Percutaneous Coronary Intervention |
| GLP-1 | Experimental | Drug: GLP-1Infusion of GLP-1 (7-36) amide during elective percutaneous coronary intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing elective PCI
- Age over 18
- Able to give informed consent
Key exclusion criteria (7 listed)
- Severe co-morbidity (expected life expectancy < 6 months)
- Nicorandil, glibenclamide, sitagliptin, vildagliptin, saxagliptin, linagliptin, liraglutide, exenatide and insulin use
- Women of child bearing age
- Breast-feeding women
- Myocardial infarction within the previous 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLP-1Also: GLP-1 (7-36) amideGLP-1 (7-36) amide infused at 1.2 pmol/Kg/min | Drug | GLP-1 |
| placeboNormal saline | Drug | Normal Saline |
Primary outcome
Plasma Troponin I level
Time frame: 6 Hours following angioplasty or stenting
Incidence of Troponin I elevation of > 5 x 99th percentile upper reference limit on blood test at approximately 6 hours post procedure.
8 secondary outcomes
Major Adverse Cardiovascular or Cerebrovascular Event (MACCE) Rates
Time frame: From date of randomisation until the date of first event assessed up to 6 months
Plasma Creatine Kinase - Myocardial Bound (CKMB) level
Time frame: 6 hours
Myocardial Flow Grade after Angioplasty or Stenting
Time frame: Measured during procedure
MACCE Rates
Time frame: From date of randomisation until the date of first event assessed up to 12 months
MACCE Rates
Time frame: From date of randomisation until the date of first event assessed up to 60 months
Ischaemic symptoms during balloon occlusion
Time frame: Assessed during procedure
Myocardial Blush Grade following angioplasty or stenting
Time frame: Measured during procedure
Electrocardiographic (ECG) Changes during procedure
Time frame: Assessed during procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Derived from this study: PubMed 31277053Giblett JP, Clarke S, Zhao T, McCormick LM, Braganza DM, Densem CG, O'Sullivan M, Adlam D, Clarke SC, Steele J, Fielding S, West NEJ, Villar SS, Hoole SP. The role of Glucagon-Like Peptide 1 Loading on periprocedural myocardial infarction During elective PCI (GOLD-PCI study): A randomized, placebo-controlled trial. Am Heart J. 2019 Sep;215:41-51. doi: 10.1016/j.ahj.2019.05.013. Epub 2019 Jun 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Hoole, MA MD FRCP principal investigator
Papworth Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GLP-1 in people with Angina Pectoris and Myocardial Infarction, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 6 Jun 2018. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Plasma Troponin I level (time frame: 6 Hours following angioplasty or stenting). 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 NCT02127996, which also lists 1 linked publication.
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 6 Jun 2018.