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Chronotherapy With Low-dose Aspirin for Primary Prevention (CARING)

Primary Purpose

Type 2 Diabetes

Status
Recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
aspirin
aspirin
Sponsored by
University of Vigo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring Aspirin, Chronotherapy, Primary prevention, Impaired fasting glucose, Type 2 diabetes, Total mortality, Myocardial infarction, Stroke, Angina pectoris, Chronic kidney disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male or female subjects ≥ 50 years of age.
  • Impaired fasting glucose (≥ 100 and < 126 mg/dl) in the last available blood test prior (≤ 3 months) to randomization, or diagnosis of type 2 diabetes prior to randomization.
  • All subjects must have at randomization a conventional clinic systolic/diastolic BP < 160/100 mmHg.
  • Informed consent to participate in the study prior to any study procedures.

Exclusion Criteria:

  • Known or suspected contraindications, including history of allergy to ASA.
  • Uncontrolled essential hypertension of Grade 2-3, i.e., systolic BP ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg before randomization.
  • Evidence of a secondary form of hypertension, to include coarctation of the aorta, hyperaldosteronism, renal artery stenosis, or pheochromocytoma.
  • Known Keith-Wagener grade III or IV hypertensive retinopathy.
  • History of hypertensive encephalopathy, cerebrovascular event, transient ischemic cerebral attack, or myocardial infarction prior to randomization.
  • Type 1 diabetes mellitus.
  • History of heart failure.
  • Second or third degree heart block without a pacemaker.
  • Concomitant unstable angina pectoris.
  • Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia.
  • Clinically significant valvular heart disease.
  • Evidence of hepatic disease as determined by one of the following: ALT or AST values > 2 x UNL known before randomization, a history of hepatic encephalopathy, history of esophageal varices, or history of portocaval shunt.
  • Diagnosis of chronic kidney disease prior to randomization.
  • History of malignancy including leukemia and lymphoma (but not basal cell skin cancer), or any other severe, life-threatening disease within the past five years.
  • Any previous history of a systemic autoimmune disease.
  • History of drug or alcohol abuse within the last two years.
  • Use of any disallowed concomitant medication.
  • Inability to communicate and comply with all study requirements.
  • Persons directly involved in the execution of this protocol.

Sites / Locations

  • CS FriolRecruiting
  • CS BaionaRecruiting
  • CS BueuRecruiting
  • CS A EstradaRecruiting
  • CS A GuardaRecruiting
  • CS ValmiñorRecruiting
  • CS PanxónRecruiting
  • CS TomiñoRecruiting
  • Bioengineering & Chronobilogy Labs., University of VigoRecruiting
  • CS Calle CubaRecruiting
  • CS A DobladaRecruiting
  • CS CoiaRecruiting
  • CS SardomaRecruiting
  • CS TeisRecruiting
  • CS VilaboaRecruiting
  • CS San RoqueRecruiting
  • CS FingoiRecruiting
  • Complexo Hospitalario Universitario de OurenseRecruiting
  • CS LerezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

100 mg/day ASA upon awakening.

100 mg/day ASA at bedtime

Outcomes

Primary Outcome Measures

To evaluate the effects of awakening vs. bedtime 100 mg/day ASA administration in subjects with impaired fasting glucose or type 2 diabetes on primary prevention of cardiovascular, cerebrovascular and renal fatal, and non-fatal events.

Secondary Outcome Measures

To evaluate the effects of awakening vs. bedtime 100 mg/day ASA administration on primary prevention of cardiovascular fatal and non-fatal events (including cardiovascular death, myocardial infarction, angina pectoris, and coronary revascularization).
To evaluate the effects of awakening vs. bedtime 100 mg/day ASA administration on primary prevention of cerebrovascular fatal and non-fatal events (including hemorrhagic stroke, ischemic stroke, and transient ischemic attack).
To evaluate the effects of awakening vs. bedtime 100 mg/day ASA administration on primary prevention of chronic kidney disease and/or congestive heart failure, and/or peripheral artery disease.
To demonstrate that 100 mg/day ASA at bedtime offers a similar safety profile than 100 mg/day ASA upon awakening
To demonstrate that compliance with 100 mg/day ASA at bedtime is similar to that with 100 mg/day ASA upon awakening.
To evaluate, for all previous objectives, potential gender differences in the benefits of low-dose ASA for primary prevention.
To evaluate, for all previous objectives, potential differences in the benefits of low-dose ASA for primary prevention between patients with and without diabetes.
To evaluate, for all previous objectives, potential differences in the benefits of low-dose ASA for primary prevention between subjects with and without metabolic syndrome.

Full Information

First Posted
July 28, 2008
Last Updated
May 8, 2023
Sponsor
University of Vigo
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1. Study Identification

Unique Protocol Identification Number
NCT00725127
Brief Title
Chronotherapy With Low-dose Aspirin for Primary Prevention
Acronym
CARING
Official Title
Chronotherapy With Low-dose Aspirin for Primary Prevention of Cardiovascular Events in Subjects With Impaired Fasting Glucose or Diabetes (CARING Study).
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2008 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vigo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Brief summary: Aspirin (ASA) has been shown to provide marked benefits in primary and secondary prevention of cardiovascular events. Substantial evidence suggests that low-dose ASA therapy should also be used as a primary prevention strategy in men and women with diabetes who are at high cardiovascular risk. On the other hand, there is current evidence on the potential benefits of low-dose ASA therapy in subjects with impaired fasting glucose, including those with metabolic syndrome. Most important, previous laboratory animal and clinical trial research convincingly demonstrates administration time-dependent (with reference to circadian rhythms) effects of ASA. Thus, the effects of ASA upon lipoperoxides, b-adrenergic receptors, and blood pressure (BP) in clinically healthy subjects depend on the circadian timing of ASA administration. The administration-time-dependent influence of ASA on BP was previously demonstrated in a randomized trial on healthy women and other independent double-blind, randomized, placebo-controlled clinical trials conducted, first, on clinically healthy subjects, a second one on normotensive and hypertensive subjects, a third one on pregnant women at high risk for preeclampsia and a fourth one in previously untreated patients with mild hypertension. The findings of these BP studies are consistent; BP-lowering effect of low-dose ASA is achieved when administered at bedtime but not upon awakening. In keeping with the chronopharmacological effects of ASA and the previous findings suggesting that ASA at low dose may exert a potential beneficial effect on BP, endothelium function and cardiovascular function, this prospective, randomized, parallel-arm study will investigate the potential influence of ASA on the primary prevention of cardiovascular, cerebrovascular and renal events in subjects with either impaired fasting glucose (≥ 100 mg/dl) or previous diagnosis of type 2 diabetes mellitus, who will receive low-dose ASA (100 mg/day) at different circadian times (upon awakening or at bedtime) in relation to their rest-activity cycle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Aspirin, Chronotherapy, Primary prevention, Impaired fasting glucose, Type 2 diabetes, Total mortality, Myocardial infarction, Stroke, Angina pectoris, Chronic kidney disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
100 mg/day ASA upon awakening.
Arm Title
2
Arm Type
Active Comparator
Arm Description
100 mg/day ASA at bedtime
Intervention Type
Drug
Intervention Name(s)
aspirin
Other Intervention Name(s)
Aspirin on awakening
Intervention Description
100 mg/day upon awakening for five years
Intervention Type
Drug
Intervention Name(s)
aspirin
Other Intervention Name(s)
Aspirin at bedtime
Intervention Description
100 mg/day at bedtime for five years
Primary Outcome Measure Information:
Title
To evaluate the effects of awakening vs. bedtime 100 mg/day ASA administration in subjects with impaired fasting glucose or type 2 diabetes on primary prevention of cardiovascular, cerebrovascular and renal fatal, and non-fatal events.
Time Frame
Five years
Secondary Outcome Measure Information:
Title
To evaluate the effects of awakening vs. bedtime 100 mg/day ASA administration on primary prevention of cardiovascular fatal and non-fatal events (including cardiovascular death, myocardial infarction, angina pectoris, and coronary revascularization).
Time Frame
Five years
Title
To evaluate the effects of awakening vs. bedtime 100 mg/day ASA administration on primary prevention of cerebrovascular fatal and non-fatal events (including hemorrhagic stroke, ischemic stroke, and transient ischemic attack).
Time Frame
Five years
Title
To evaluate the effects of awakening vs. bedtime 100 mg/day ASA administration on primary prevention of chronic kidney disease and/or congestive heart failure, and/or peripheral artery disease.
Time Frame
Five years
Title
To demonstrate that 100 mg/day ASA at bedtime offers a similar safety profile than 100 mg/day ASA upon awakening
Time Frame
Five years
Title
To demonstrate that compliance with 100 mg/day ASA at bedtime is similar to that with 100 mg/day ASA upon awakening.
Time Frame
Five years
Title
To evaluate, for all previous objectives, potential gender differences in the benefits of low-dose ASA for primary prevention.
Time Frame
Five years
Title
To evaluate, for all previous objectives, potential differences in the benefits of low-dose ASA for primary prevention between patients with and without diabetes.
Time Frame
Five years
Title
To evaluate, for all previous objectives, potential differences in the benefits of low-dose ASA for primary prevention between subjects with and without metabolic syndrome.
Time Frame
Five years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female subjects ≥ 50 years of age. Impaired fasting glucose (≥ 100 and < 126 mg/dl) in the last available blood test prior (≤ 3 months) to randomization, or diagnosis of type 2 diabetes prior to randomization. All subjects must have at randomization a conventional clinic systolic/diastolic BP < 160/100 mmHg. Informed consent to participate in the study prior to any study procedures. Exclusion Criteria: Known or suspected contraindications, including history of allergy to ASA. Uncontrolled essential hypertension of Grade 2-3, i.e., systolic BP ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg before randomization. Evidence of a secondary form of hypertension, to include coarctation of the aorta, hyperaldosteronism, renal artery stenosis, or pheochromocytoma. Known Keith-Wagener grade III or IV hypertensive retinopathy. History of hypertensive encephalopathy, cerebrovascular event, transient ischemic cerebral attack, or myocardial infarction prior to randomization. Type 1 diabetes mellitus. History of heart failure. Second or third degree heart block without a pacemaker. Concomitant unstable angina pectoris. Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia. Clinically significant valvular heart disease. Evidence of hepatic disease as determined by one of the following: ALT or AST values > 2 x UNL known before randomization, a history of hepatic encephalopathy, history of esophageal varices, or history of portocaval shunt. Diagnosis of chronic kidney disease prior to randomization. History of malignancy including leukemia and lymphoma (but not basal cell skin cancer), or any other severe, life-threatening disease within the past five years. Any previous history of a systemic autoimmune disease. History of drug or alcohol abuse within the last two years. Use of any disallowed concomitant medication. Inability to communicate and comply with all study requirements. Persons directly involved in the execution of this protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ramon C Hermida, PhD
Phone
34986812148
Email
rhermida@uvigo.es
First Name & Middle Initial & Last Name or Official Title & Degree
Diana E Ayala, MD, PhD
Phone
34986812148
Email
dianaelva@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramon C Hermida, PhD
Organizational Affiliation
University of Vigo
Official's Role
Study Director
Facility Information:
Facility Name
CS Friol
City
Friol
State/Province
Lugo
ZIP/Postal Code
27220
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esther Gomez, MD
Phone
34639512093
Email
Esther.Gomez.Sal@sergas.es
First Name & Middle Initial & Last Name & Degree
Esther Gomez, MD
Facility Name
CS Baiona
City
Baiona
State/Province
Pontevedra
ZIP/Postal Code
36300
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco J Iglesias, MD
Phone
34986357239
Email
FranciscoJavier.Iglesias.Mato@sergas.es
First Name & Middle Initial & Last Name & Degree
Francisco J Iglesias, MD
Facility Name
CS Bueu
City
Bueu
State/Province
Pontevedra
ZIP/Postal Code
36930
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel A Aboal, MD
Phone
34986323313
Email
miguel.angel.aboal.beato@sergas.es
First Name & Middle Initial & Last Name & Degree
Miguel A Aboal, MD
Facility Name
CS A Estrada
City
La Estrada
State/Province
Pontevedra
ZIP/Postal Code
26680
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Meijide, MD
Phone
34986573459
Email
Luis.Meijide.Calvo@sergas.es
First Name & Middle Initial & Last Name & Degree
Luis Meijide, MD
First Name & Middle Initial & Last Name & Degree
Mariana Carbon, MD
First Name & Middle Initial & Last Name & Degree
Maria C Garcia, MD
First Name & Middle Initial & Last Name & Degree
Francisco Romero, MD
First Name & Middle Initial & Last Name & Degree
Maria P Brea
Facility Name
CS A Guarda
City
La Guardia
State/Province
Pontevedra
ZIP/Postal Code
36780
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan J Crespo, MD
Phone
34986614450
Email
JuanJose.Crespo.Sabaris@sergas.es
First Name & Middle Initial & Last Name & Degree
Juan J Crespo, MD
First Name & Middle Initial & Last Name & Degree
Raquel Fernandez, MD
First Name & Middle Initial & Last Name & Degree
Carmen M Fernandez, MD
First Name & Middle Initial & Last Name & Degree
Amelia Ferreras, MD
First Name & Middle Initial & Last Name & Degree
Manuel F Quintans, MD
First Name & Middle Initial & Last Name & Degree
Javier Rodriguez, MD
First Name & Middle Initial & Last Name & Degree
Pilar Rua
First Name & Middle Initial & Last Name & Degree
Aurelio Alvarez
First Name & Middle Initial & Last Name & Degree
Asuncion Cadilla
First Name & Middle Initial & Last Name & Degree
Carmen Outeiro
First Name & Middle Initial & Last Name & Degree
Carmen Soto-Davila
Facility Name
CS Valmiñor
City
Nigran
State/Province
Pontevedra
ZIP/Postal Code
36250
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susana Hernaiz, MD
Phone
34655391498
Email
Susana.Hernaiz.Valero@sergas.es
First Name & Middle Initial & Last Name & Degree
Susana Hernaiz, MD
Facility Name
CS Panxón
City
Nigrán
State/Province
Pontevedra
ZIP/Postal Code
36340
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose L Salgado, MD
Phone
34986368615
Email
joseluis.salgado.conde@sergas.es
First Name & Middle Initial & Last Name & Degree
Jose L Salgado, MD
First Name & Middle Initial & Last Name & Degree
Esperanza Parrado
First Name & Middle Initial & Last Name & Degree
Alfredo Pereira
Facility Name
CS Tomiño
City
Tomiño
State/Province
Pontevedra
ZIP/Postal Code
36200
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evangelina Filloy, MD
Phone
34-986-623411
Email
evangelina.filloy.miguez@sergas.es
First Name & Middle Initial & Last Name & Degree
Evangelina Filloy, MD
First Name & Middle Initial & Last Name & Degree
Adolfo T Perez, MD
First Name & Middle Initial & Last Name & Degree
Nieves Turienzo, MD
First Name & Middle Initial & Last Name & Degree
Dolores Cardalda
First Name & Middle Initial & Last Name & Degree
Jose C Varela
First Name & Middle Initial & Last Name & Degree
Francisca Vazquez
Facility Name
Bioengineering & Chronobilogy Labs., University of Vigo
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36200
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramon C Hermida, PhD
Phone
34986812148
Email
rhermida@uvigo.es
First Name & Middle Initial & Last Name & Degree
Diana E Ayala, MD, PhD
Phone
34986812148
Email
dianaelva@uvigo.es
First Name & Middle Initial & Last Name & Degree
Ramon C Hermida, PhD
First Name & Middle Initial & Last Name & Degree
Diana E Ayala, MD, PhD
First Name & Middle Initial & Last Name & Degree
Artemio Mojon, PhD
First Name & Middle Initial & Last Name & Degree
Jose R Fernandez, PhD
First Name & Middle Initial & Last Name & Degree
Ignacio Alonso, PhD
First Name & Middle Initial & Last Name & Degree
Maria J Fontao
First Name & Middle Initial & Last Name & Degree
Rita Soler
First Name & Middle Initial & Last Name & Degree
Susana Serrano
Facility Name
CS Calle Cuba
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36202
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felisa Dominguez, MD
Phone
34986416226
Email
fdominguez@meditex.es
First Name & Middle Initial & Last Name & Degree
Felisa Dominguez, MD
Facility Name
CS A Doblada
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36205
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Rios, MD
Phone
34986275121
Email
teresa.rios.rey@sergas.es
First Name & Middle Initial & Last Name & Degree
Teresa Rios, MD
Facility Name
CS Coia
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36209
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peregrina Eiroa, MD
Phone
34986209282
Email
pereeiroa@telefonica.net
First Name & Middle Initial & Last Name & Degree
Peregrina Eiroa, MD
First Name & Middle Initial & Last Name & Degree
Jesus C Nieto, MD
Facility Name
CS Sardoma
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36214
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Dominguez, MD, PhD
Phone
34986416324
Email
Manuel.Dominguez.Sardina@sergas.es
First Name & Middle Initial & Last Name & Degree
Manuel Dominguez, MD, PhD
Facility Name
CS Teis
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36216
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro A Callejas, MD
Phone
34986374229
Email
PedroAntonio.Callejas.Cabanillas@sergas.es
First Name & Middle Initial & Last Name & Degree
Pedro A Callejas, MD
Facility Name
CS Vilaboa
City
Vilaboa
State/Province
Pontevedra
ZIP/Postal Code
36141
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia M Gomara, MD
Phone
34986679229
Email
SoniaMaria.Gomara.Villabona@sergas.es
First Name & Middle Initial & Last Name & Degree
Sonia M Gomara, MD
First Name & Middle Initial & Last Name & Degree
Julio J Alvarez, MD
First Name & Middle Initial & Last Name & Degree
Margarita Estevez
First Name & Middle Initial & Last Name & Degree
Maria C Ferreira
Facility Name
CS San Roque
City
Vilagarcía De Arousa
State/Province
Pontevedra
ZIP/Postal Code
36600
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Envira Sineiro, MD
Phone
34986507448
Email
Elvira.Sineiro.Galinanes@sergas.es
First Name & Middle Initial & Last Name & Degree
Elvira Sineiro, MD
First Name & Middle Initial & Last Name & Degree
Margarita Alvariño
First Name & Middle Initial & Last Name & Degree
Luis M Fontenla
First Name & Middle Initial & Last Name & Degree
Margarita Fraga, MD
First Name & Middle Initial & Last Name & Degree
Barbara Llovo
First Name & Middle Initial & Last Name & Degree
Rita Martinez
First Name & Middle Initial & Last Name & Degree
Santiago Santidrian, MD
Facility Name
CS Fingoi
City
Lugo
ZIP/Postal Code
27002
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Castiñeira, MD
Phone
34982251035
Email
Carmen.Castineira.Perez@sergas.es
First Name & Middle Initial & Last Name & Degree
Carmen Castiñeira, MD
First Name & Middle Initial & Last Name & Degree
Maria C Aguado
First Name & Middle Initial & Last Name & Degree
Carmen Costa
First Name & Middle Initial & Last Name & Degree
Domingo D Garcia, MD
First Name & Middle Initial & Last Name & Degree
Bernardino Pardo, MD
First Name & Middle Initial & Last Name & Degree
Enrique J Vazquez, MD
Facility Name
Complexo Hospitalario Universitario de Ourense
City
Orense
ZIP/Postal Code
32005
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfonso Otero, MD, PhD
Phone
34988385625
Email
Alfonso.Santiago.Otero.Gonzalez@sergas.es
First Name & Middle Initial & Last Name & Degree
Alfonso Otero, MD, PhD
Facility Name
CS Lerez
City
Pontevedra
ZIP/Postal Code
36156
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Moya, MD
Phone
34986871496
Email
ana.moya.alvarez@sergas.es
First Name & Middle Initial & Last Name & Degree
Ana Moya, MD
First Name & Middle Initial & Last Name & Degree
Andres Ruiz, MD
First Name & Middle Initial & Last Name & Degree
Aurelia Constenla
First Name & Middle Initial & Last Name & Degree
Maria I Franco

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://www.hygia.es
Description
Related Info

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Chronotherapy With Low-dose Aspirin for Primary Prevention

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