Condition category
Circulatory System
Date applied
11/10/2007
Date assigned
11/01/2008
Last edited
02/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Antonio Fernandez-Ortiz

ORCID ID

Contact details

c/o Prof Martin Lagos
sn
Hospital Clínico San Carlos
Unidad Coronaria
Madrid
28040
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

CHIPS

Study hypothesis

A tight glucose control with intravenous insulin in patients suffering from acute coronary syndrome (ACS) would decrease their platelet reactivity compared to subcutaneous insulin.

On 26/06/2008 the sources of funding field was changed from 'Grant application submitted to the Spanish Foundation for Investigation in Science (FIS). Decision pending as of 11/01/2008' to 'Foundation for Development and Cardiovascular Research (Spain)'.

On 10/08/2009 the following changes were made to the trial record:
1. The target number of participants was changed from 200 to 115.
2. The sources of funding was changed from 'Foundation for Development and Cardiovascular Research (Spain)' to 'Foundation for Cardiovascular Research (Fundación Investigación Cardiovascular [FIC]) (Spain)'.

Ethics approval

Local Ethics Committee of the Hospital Clinico San Carlos (Coordinación de ensayos clinicos del Hospital Clinico San Carlos), 07/03/2007, amendments approved 12/12/2007, ref: 07/062

Study design

Open single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Acute coronary syndrome

Intervention

Patients are randomised to one of two protocols of glycaemic control.

Intervention group (therapy A): intensive treatment. The aim was to obtain a glycaemia of 80 to 120 mg/dl (4.44 to 6.66 mmol/l). Infusion of insulin is started and hourly controls of the rate of infusion was carried out according to a chart elaborated by the Diabetes Unit of our centre. After 24 hours of insulin infusion, a nocturnal dose of ultra-slow insulin was calculated, together with fast subcutaneous insulin before meals.

Control group (therapy B): standard treatment. The aim was to obtain a glycaemia of less than 180 mg/dl (9.99 mmol/l). The participants were treated with fast subcutaneous insulin before meals, according to a corrective chart, together with slow insulin twice a day (bid). In patients diagnosed with diabetes, the dose of slow insulin was calculated from their previous treatment or according to the weight (0.1 unit per kilogram every 12 h)

As of 10/08/2009, recruitment has ended for this trial. The last patient was recruited on 29/07/2009.

Intervention type

Drug

Phase

Not Applicable

Drug names

Insulin

Primary outcome measures

1. Effects of treatment on platelet reactivity. Platelet reactivity at baseline, 24 and 48 hours will be assessed by the following:
1.1. Platelet activation: flow cytometry; analysis of platelet P-selectin and GPIIb/IIIa, basal and activated with ADP (1 and 5 µM) and thrombin receptor activating peptide (TRAP) (1 and 5 µM)
1.2. Intracellular expression of vasodilator-stimulated phosphoprotein (VASP)
1.3. Soluble sCD40L
1.4. Platelet aggregation
2. Metabolic study: free fatty acids, leptin, adiponectin, and ßOH-butirate. They will be assessed at baseline, 24 and 48 hours, 3, 6, 9 and 12 months of follow-up
3. Influence of platelet polymorphisms on treatment effects. Genetic polymorphisms will be assessed by polymerase chain reaction (PCR) for P-selectin receptor, platelet ADP receptor and phospholipase A2 receptor (PLA2) receptor of GPIIb/IIIa

Secondary outcome measures

Current secondary outcome measures as of 10/08/2009:
Association between the parameters above and cardiovascular major events during follow-up, between different levels of glycaemia, different evolution of diabetes mellitus (quantified by HbA1c, ages of evolution, type of treatment)

Previous secondary outcome measures:
Clinical outcome: association between the parameters above and cardiovascular major events during follow-up. Cardiovascular major events (death, reinfarction, angina, revascularisation, ictus, cardiogenic shock, pulmonary oedema) during follow-up will be recorded.

Overall trial start date

26/03/2007

Overall trial end date

26/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Consecutive patients admitted to the Coronary Care Unit with ACS and hyperglycaemia will be enrolled if they meet the following criteria:
1. Chest pain in the 24 hours previous to their inclusion
2. Older than 18 years
3. Written informed consent
4. Participant must have one of the following:
4.1. ST segment elevation of at least 0.1 mV in two or more adjacent leads
4.2. New onset left bundle branch block
4.3. ST segment depression of at least 0.1 mV in two or more adjacent leads
4.4. Markers of myocardial necrosis (cardiac troponin I above normal levels)
5. Participants must have one of the following:
5.1. Known diabetes and glycaemia greater than 120 mg/dl (6.66 mmol/l) on admission
5.2. No diagnosis of diabetes and glycaemia greater than 160 mg/dl (8.88 mmol/l) on admission
5.3. No diagnosis of diabetes and glycaemia between 120 to 160 mg/dl at admission, and greater than 120 mg/dl one hour later

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

115 (added 10/08/2009)

Participant exclusion criteria

1. Women of childbearing age
2. Inclusion in another clinical trial
3. Life expectancy of less than 1 year
4. High probability of loss on follow-up
5. Unclear origin of chest pain
6. Patients with scheduled percutaneous coronary interventions with complications during the procedure and are admitted to the Coronary Unit, but without chest pain in the last 24 hours
7. Patients on mechanical ventilation
8. Ethical barriers (e.g., patients who are not fluent in Spanish, relatives of investigators)
9. Glycaemia greater than 400 mg% (22.20 mmol/l) on admission

Recruitment start date

26/03/2007

Recruitment end date

26/03/2009

Locations

Countries of recruitment

Spain

Trial participating centre

c/o Prof Martin Lagos, sn
Madrid
28040
Spain

Sponsor information

Organisation

Hospital Clínico San Carlos, Instituto Cardiovascular (Spain)

Sponsor details

c/o Prof Martin Lagos
sn
Cardiology Department
Madrid
28040
Spain

Sponsor type

Hospital/treatment centre

Website

http://www.hcsc.es

Funders

Funder type

Research organisation

Funder name

Foundation for Cardiovascular Research (Fundación Investigación Cardiovascular [FIC]) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21378389

Publication citations

  1. Results

    Vivas D, García-Rubira JC, Bernardo E, Angiolillo DJ, Martín P, Calle-Pascual A, Núñez-Gil I, Macaya C, Fernández-Ortiz A, Effects of intensive glucose control on platelet reactivity in patients with acute coronary syndromes. Results of the CHIPS Study ("Control de Hiperglucemia y Actividad Plaquetaria en Pacientes con Sindrome Coronario Agudo")., Heart, 2011, 97, 10, 803-809, doi: 10.1136/hrt.2010.219949.

Additional files

Editorial Notes