Diabetes Mellitus, Type 2Phase 4PREDICTNCT02698618
PRotective Effect on the Coronary Microcirculation of Patients With DIabetes by Clopidogrel or Ticagrelor
A Phase 4 study testing Diagnostic, Randomization and PCI in people with Diabetes Mellitus, Type 2, run by Fundacion Investigacion Interhospitalaria Cardiovascular at 3 sites in Spain.
Trial summary
The purpose of this study is to determine whether Ticagrelor has a protective effect on microcirculation during percutaneous coronary interventions in patients with Diabetes mellitus type II or in a pre-diabetic status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Diagnostic, Randomization and PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesSpain
- Study dates
- Mar 2016to Mar 2017
- Phase
- Phase 4
- 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
- Subject with Diabetes Mellitus (DM) Type II
- Subject must be older than 18 years
- Written informed consent available
- Subject with stable ischemic heart disease referred for coronary angiography
- Subject is eligible for PCI, and PCI target(s) have FFR≤0.80
Who cannot join
- Prior myocardial infarction in the territory of the target vessel
- Akinesia or dyskinesia in subtended myocardial segments
- Severe impairment of left ventricular function (LVEF) <35%
- PCI target is a chronic total occlusion
- Target lesion has been treated previously (restenotic lesions)
- Target vessel is a saphenous vein graft or a surgical graft has been anastomosed to target vessel
Show all 18Show fewer
- Thrombolisis in Myocardial Infarction (TIMI) flow ≤ 1 prior to guide wire crossing
- Subject is not eligible for treatment with DES
- Bleeding disorders or chronic anticoagulant treatment
- Left main stenosis > 50%
- Coronary surgery deemed more beneficial for the patient than PCI
- Intolerance or contraindications to anti-platelet drugs
- Contraindications for adenosine administration
- Platelet count <75000 or >700000/mm3
- Immunosuppressive therapy
- Pregnant or breast feeding patient
- History of intracranial haemorrhage
- Severe hepatic impairment
Trial locations and contacts
3 sites in 1 country.
Enrico Cerrato, MD contact
Spain3 sites
Hospital Galdakao-Usansolo
Bilbao, Vizcaya, 48960
José R Rumoroso, MD, PhD, +34 944007000
José R Rumoroso, MD, PhD
Hospital San Carlos
Madrid, Madrid, 28040
Javier Escaned, MD, PhD, +34913303438, javier.escaned@salud.madrid.org
Enrico Cerrato, MD, enrico.cerrato@gmail.com
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
José M de la Torre, MD, PhD, +34 942202520
José M de la Torre, MD, PhD
About this study
The purpose of this study is to determine whether Ticagrelor has a protective effect on microcirculation during percutaneous coronary interventions in patients with Diabetes mellitus type II or in a pre-diabetic status.
Read the detailed description
Introduction:
Patients with Diabetes Mellitus (DM) Type 2 still consistently perform worse than their non-diabetic counterparts especially in the setting of Percutaneous Coronary Intervention (PCI). The abnormal coronary microcirculation along with the higher risk of distal embolization of particles released from the PCI target lesion constitutes the main cause of peri-procedural microcirculatory damage.
New antiplatelet agents, in particular Ticagrelor, might also play a protective role on microcirculation. Ticagrelor inhibits cellular uptake of adenosine, increasing the circulating levels of adenosine through the inhibition of its physiological clearance. Adenosine may protect the myocardium from both ischemic, and reperfusion injury via its potent vasodilatory effects and possibly by anti-inflammatory and antiplatelet properties.
Additionally previous research have identified a more profound effect of adenosine on microcirculatory resistance associated to obesity and diabetes and a higher myocardial protective effect of Ticagrelor during PCI might be expected in this high risk subgroup of patients.
The purpose of PRotective Effect on the Coronary Microcirculation of Patients With DIabetes by Clopidogrel or Ticagrelor (PREDICT) trial was designed to investigate the protective effect of Ticagrelor on microcirculation during PCI in stable diabetic patient
Rationale:
- Coronary plaques at high risk for distal embolization during PCI, like the one with thin-cap fibroatheroma (TCFA), are more prevalent in patient with DM. Thus, this population is at high risk to develop myocardial injury and microcirculation impairment subsequent to PCI.
- By blocking the Adenosine transporter (ENT) 1 nucleoside cell membrane transporter, Ticagrelor inhibits cellular uptake of adenosine, increasing the circulating levels of adenosine through the inhibition of its physiological clearance. Adenosine may protect the myocardium from both ischemic, and reperfusion injury via its potent vasodilatory effects and possibly by anti-inflammatory and antiplatelet properties. This translates into an adenosine-mediated vasodilatory effect of ticagrelor that takes place soon after loading dose.
- Previous research from our group have identified a more profound effect of adenosine on microcirculatory resistance associated to obesity and diabetes and a higher myocardial protective effect of Ticagrelor during PCI might be expected in this high risk subgroup of patients. (enhanced microcirculatory response to raised adenosine levels).
Giving these premises in diabetics or pre-diabetics patients, Ticagrelor treatment pre-PCI might improve microcirculatory parameters (lower resistance) compared with clopidogrel (secondary hypothesis). Ticagrelor might be superior to clopidogrel in providing microcirculatory protection during PCI procedures in the same subgroup of patients (primary hypothesis).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Diagnostic, Randomization, PCI
- Keywords
- Diabetes, IMR, Microcirculation, Ticagrelor, CFR, FFR, Coronary microcirculation
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiagnosticProcedure or surgery
Pre-PCI and treatment:
- At hospital admission: all consecutive patients referred for coronary angiography in stable ischemic heart disease will undergo a complete physical examination, Electrocardiogram (ECG) and laboratory blood testing including cardiac troponin and kinase mioband. Subjects will be investigated to confirm or diagnose existing diabetic or pre-diabetic status.
- At the time of diagnostic catheterization After informed consent, diabetic or pre-diabetic patients with at least one stenosis with a Fractional Flow Reserve value (FFR) ≤ 0.80 fulfilling all the inclusion/exclusion criteria will be included in the trial.At the same time, a multimodal physiology assessment, including Coronary Flow Reserve (CFR) and Index of Microcirculatory Resistance (IMR) will be measured.
RandomizationDrug
Randomization: patients will be randomly assigned (with 1:1 ratio) to receive either Clopidogrel or Ticagrelor before their clinically-indicated Percutaneous Coronary Intervention (PCI). Either a loading dose of Ticagrelor 180mg followed by a dose of 90mg b.i.d. (during 48 hours) or a loading dose of Clopidogrel 600mg followed by a daily dose (during at least 48 hours) of 75mg will be administered according to their randomization. Additionally the groups will be balanced according to obesity prevalence [Body Mass Index (BMI) ≥30 kg/m2] with the implementation of a dedicated randomization list.
PCIProcedure or surgery
- Pre-PCI: multimodal physiological evaluation: FFR, CFR, IMR will be repeated
- PCI: For all the patients undergoing PCI, the use of unfractioned heparin (UHF) will be allowed at the time of PCI; UFH be administered with a target on Activated Clotting Time (ACT) of 200-250 s. The PCI procedures will be performed by standard technique using only second generation Drug Eluting Stents (DES). In all cases, balloon pre-dilatation will be performed before stent implantation using a semi-compliant balloon with a diameter lower than a 75% of the distal reference diameter of the vessel to avoid confounders Post-dilation will be performed according to clinical practice although it will be not mandatory.
- Post-PCI: After stent implantation/s, multimodal physiological evaluation will be re-performed (FFR, CFR, IMR).
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Experimental | A loading dose of Ticagrelor 180mg followed by a dose of 90mg b.i.d. (during 48 hours) Receives: Procedure: Diagnostic; Drug: Randomization; Procedure: PCI |
| Clopidogrel | Active comparator | A loading dose of Clopidogrel 600mg followed by a daily dose (during at least 48 hours) of 75mg Receives: Procedure: Diagnostic; Drug: Randomization; Procedure: PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta IMR post-PCI
Absolute difference in the IMR value associated to PCI ["Delta IMR Post-PCI" = (IMR value post-PCI) minus (IMR value pre-PCI)]
Measured: at least 48 hours after randomization, just after PCI and stenting.
Delta IMR pre-PCI
Absolute difference in the IMR value associated to PCI ["Delta IMR Pre-PCI" = (IMR value pre-PCI) minus (IMR value at baseline)]
Measured: at least 48 hours after randomization, just before PCI and stenting.
Secondary outcomes (3)
Myocardial necrosis associated to PCI damage
Myocardial necrosis associated to PCI damage, assessed by cardiac markers (troponin rise > 5 times 99th percentile of upper reference limit or as elevation of CK-MB 3 times the upper limit of normal
Measured: at least 72 hours, at the time of hospital discharge.
IMR post-PCI
Absolute resistance value after PCI
Measured: at least 48 hours after randomization, just after PCI and stenting.
Severe microcirculatory impairment
Incidence of severe microcirculatory impairment defined as Index of Microvascular Resistance > 29 after PCI
Measured: at least 48 hours after randomization, just after PCI and stenting.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (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 Diabetes Mellitus, Type 2Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Investigacion Interhospitalaria Cardiovascular
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Javier Escaned, Hospital San Carlos, Madrid
- Investigators
- Javier Escaned, MD, PhD, Principal investigator, Hospital San Carlos, Madrid, SpainEnrico Cerrato, MD, Principal investigator, San Luigi Gonzaga University Hospital, Orbassano (Turin), Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698618
- Sponsor's protocol ID
- ESR-15-10793
- Other IDs
- 2015-003621-33, 2015
- Acronym
- PREDICT
- Status last verified
- Feb 2016
- First submitted
- 11 Feb 2016
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Cerrato E, Quiros A, Echavarria-Pinto M, Mejia-Renteria H, Aldazabal A, Ryan N, Gonzalo N, Jimenez-Quevedo P, Nombela-Franco L, Salinas P, Nunez-Gil IJ, Rumoroso JR, Fernandez-Ortiz A, Macaya C, Escaned J. PRotective Effect on the coronary microcirculation of patients with DIabetes by Clopidogrel or Ticagrelor (PREDICT): study rationale and design. A randomized multicenter clinical trial using intracoronary multimodal physiology. Cardiovasc Diabetol. 2017 May 19;16(1):68. doi: 10.1186/s12933-017-0543-5.
PubMed 28526024
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRotective Effect on the Coronary Microcirculation of Patients With DIabetes by Clopidogrel or Ticagrelor
- ClinicalTrials.gov ID
- NCT02698618
- Acronym / sponsor ID
- PREDICT / ESR-15-10793
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes, IMR, Microcirculation, Ticagrelor, CFR, FFR, Coronary microcirculation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fundacion Investigacion Interhospitalaria CardiovascularUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 4 Mar 2016 (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.
The purpose of this study is to determine whether Ticagrelor has a protective effect on microcirculation during percutaneous coronary interventions in patients with Diabetes mellitus type II or in a pre-diabetic status.
Detailed description
Introduction:
Patients with Diabetes Mellitus (DM) Type 2 still consistently perform worse than their non-diabetic counterparts especially in the setting of Percutaneous Coronary Intervention (PCI). The abnormal coronary microcirculation along with the higher risk of distal embolization of particles released from the PCI target lesion constitutes the main cause of peri-procedural microcirculatory damage.
New antiplatelet agents, in particular Ticagrelor, might also play a protective role on microcirculation. Ticagrelor inhibits cellular uptake of adenosine, increasing the circulating levels of adenosine through the inhibition of its physiological clearance. Adenosine may protect the myocardium from both ischemic, and reperfusion injury via its potent vasodilatory effects and possibly by anti-inflammatory and antiplatelet properties.
Additionally previous research have identified a more profound effect of adenosine on microcirculatory resistance associated to obesity and diabetes and a higher myocardial protective effect of Ticagrelor during PCI might be expected in this high risk subgroup of patients.
The purpose of PRotective Effect on the Coronary Microcirculation of Patients With DIabetes by Clopidogrel or Ticagrelor (PREDICT) trial was designed to investigate the protective effect of Ticagrelor on microcirculation during PCI in stable diabetic patient
Rationale:
- Coronary plaques at high risk for distal embolization during PCI, like the one with thin-cap fibroatheroma (TCFA), are more prevalent in patient with DM. Thus, this population is at high risk to develop myocardial injury and microcirculation impairment subsequent to PCI.
- By blocking the Adenosine transporter (ENT) 1 nucleoside cell membrane transporter, Ticagrelor inhibits cellular uptake of adenosine, increasing the circulating levels of adenosine through the inhibition of its physiological clearance. Adenosine may protect the myocardium from both ischemic, and reperfusion injury via its potent vasodilatory effects and possibly by anti-inflammatory and antiplatelet properties. This translates into an adenosine-mediated vasodilatory effect of ticagrelor that takes place soon after loading dose.
- Previous research from our group have identified a more profound effect of adenosine on microcirculatory resistance associated to obesity and diabetes and a higher myocardial protective effect of Ticagrelor during PCI might be expected in this high risk subgroup of patients. (enhanced microcirculatory response to raised adenosine levels).
Giving these premises in diabetics or pre-diabetics patients, Ticagrelor treatment pre-PCI might improve microcirculatory parameters (lower resistance) compared with clopidogrel (secondary hypothesis). Ticagrelor might be superior to clopidogrel in providing microcirculatory protection during PCI procedures in the same subgroup of patients (primary hypothesis).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Experimental | Procedure: Diagnostic, Drug: Randomization, Procedure: PCIA loading dose of Ticagrelor 180mg followed by a dose of 90mg b.i.d. (during 48 hours) |
| Clopidogrel | Active comparator | Procedure: Diagnostic, Drug: Randomization, Procedure: PCIA loading dose of Clopidogrel 600mg followed by a daily dose (during at least 48 hours) of 75mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject with Diabetes Mellitus (DM) Type II
- Subject must be older than 18 years
- Written informed consent available
- Subject with stable ischemic heart disease referred for coronary angiography
- Subject is eligible for PCI, and PCI target(s) have FFR≤0.80
Key exclusion criteria (18 listed)
- Prior myocardial infarction in the territory of the target vessel
- Akinesia or dyskinesia in subtended myocardial segments
- Severe impairment of left ventricular function (LVEF) <35%
- PCI target is a chronic total occlusion
- Target lesion has been treated previously (restenotic lesions)
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 |
|---|---|---|
| DiagnosticPre-PCI and treatment: 1. At hospital admission: all consecutive patients referred for coronary angiography in stable ischemic heart disease will undergo a complete physical examination, Electrocardiogram (ECG) and laboratory blood testing including cardiac troponin and kinase mioband. Subjects will be investigated to confirm or diagnose existing diabetic or pre-diabetic status. 2. At the time of diagnostic catheterization After informed consent, diabetic or pre-diabetic patients with at least one stenosis with a Fractional Flow Reserve value (FFR) ≤ 0.80 fulfilling all the inclusion/exclusion criteria will be included in the trial.At the same time, a multimodal physiology assessment, including Coronary Flow Reserve (CFR) and Index of Microcirculatory Resistance (IMR) will be measured. | Procedure or surgery | Clopidogrel, Ticagrelor |
| RandomizationRandomization: patients will be randomly assigned (with 1:1 ratio) to receive either Clopidogrel or Ticagrelor before their clinically-indicated Percutaneous Coronary Intervention (PCI). Either a loading dose of Ticagrelor 180mg followed by a dose of 90mg b.i.d. (during 48 hours) or a loading dose of Clopidogrel 600mg followed by a daily dose (during at least 48 hours) of 75mg will be administered according to their randomization. Additionally the groups will be balanced according to obesity prevalence [Body Mass Index (BMI) ≥30 kg/m2] with the implementation of a dedicated randomization list. | Drug | Clopidogrel, Ticagrelor |
| PCI1. Pre-PCI: multimodal physiological evaluation: FFR, CFR, IMR will be repeated 2. PCI: For all the patients undergoing PCI, the use of unfractioned heparin (UHF) will be allowed at the time of PCI; UFH be administered with a target on Activated Clotting Time (ACT) of 200-250 s. The PCI procedures will be performed by standard technique using only second generation Drug Eluting Stents (DES). In all cases, balloon pre-dilatation will be performed before stent implantation using a semi-compliant balloon with a diameter lower than a 75% of the distal reference diameter of the vessel to avoid confounders Post-dilation will be performed according to clinical practice although it will be not mandatory. 3. Post-PCI: After stent implantation/s, multimodal physiological evaluation will be re-performed (FFR, CFR, IMR). | Procedure or surgery | Clopidogrel, Ticagrelor |
Primary outcome
Delta IMR post-PCI
Time frame: at least 48 hours after randomization, just after PCI and stenting.
Absolute difference in the IMR value associated to PCI ["Delta IMR Post-PCI" = (IMR value post-PCI) minus (IMR value pre-PCI)]
Delta IMR pre-PCI
Time frame: at least 48 hours after randomization, just before PCI and stenting.
Absolute difference in the IMR value associated to PCI ["Delta IMR Pre-PCI" = (IMR value pre-PCI) minus (IMR value at baseline)]
3 secondary outcomes
Myocardial necrosis associated to PCI damage
Time frame: at least 72 hours, at the time of hospital discharge.
IMR post-PCI
Time frame: at least 48 hours after randomization, just after PCI and stenting.
Severe microcirculatory impairment
Time frame: at least 48 hours after randomization, just after PCI and stenting.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
- Derived from this study: PubMed 28526024Cerrato E, Quiros A, Echavarria-Pinto M, Mejia-Renteria H, Aldazabal A, Ryan N, Gonzalo N, Jimenez-Quevedo P, Nombela-Franco L, Salinas P, Nunez-Gil IJ, Rumoroso JR, Fernandez-Ortiz A, Macaya C, Escaned J. PRotective Effect on the coronary microcirculation of patients with DIabetes by Clopidogrel or Ticagrelor (PREDICT): study rationale and design. A randomized multicenter clinical trial using intracoronary multimodal physiology. Cardiovasc Diabetol. 2017 May 19;16(1):68. doi: 10.1186/s12933-017-0543-5.
- Individual participant dataSharing planned: Undecided
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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.
Enrico Cerrato, MD contact
Javier Escaned, MD, PhD principal investigator
Hospital San Carlos, Madrid, Spain
Enrico Cerrato, MD principal investigator
San Luigi Gonzaga University Hospital, Orbassano (Turin), Italy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diagnostic, Randomization and PCI in people with Diabetes Mellitus, Type 2, run by Fundacion Investigacion Interhospitalaria Cardiovascular at 3 sites in Spain.
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 5 inclusion and 18 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 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Javier Escaned, MD, PhD (+34913303438, javier.escaned@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delta IMR post-PCI (time frame: at least 48 hours after randomization, just after PCI and stenting.). The study lists 2 primary outcomes in all. 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 NCT02698618, 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 4 Mar 2016.